Surg Endosc (2005) 19: 148–151 DOI: 10.1007/s00464-004-9043-2
Springer Science+Business Media, Inc. 2004

A prospective randomized trial of closing laparoscopic trocar wounds by transcutaneous vs subcuticular suture or adhesive papertape O. Buchweitz, P. Wu¨lfing, L. Kiesel Department of Obstetrics and Gynecology, University of Mu¨nster, Albert-Schweitzer-Strasse 33, D-48149 Mu¨nster, Germany Received: 19 February 2004/Accepted: 16 July 2004/Online publication: 18 November 2004

Abstract Background: Several methods for closure of trocar wounds are known in laparoscopic surgery. The choice of technique (mostly transcutaneous or subcuticular suture or adhesive papertape) is often based on the surgeon’s personal experience. Thus, the objective of this trial was to assess the impact of these closure methods on potential complications of wound healing, cosmetic outcome, and patient satisfaction. Methods: Sixty patients undergoing operative laparoscopic surgery for gynecologic indications were enrolled in this prospective randomized trial. Five-millimeter port-site incisions were closed either with subcuticular or transcutaneous absorbable sutures (4–0 polyglactin 910) or with adhesive papertape. Postoperative complications, pain, and patient satisfaction with scars were evaluated at 3-month follow-up after operation using a questionnaire. Results: Data from 52 patients who returned the questionnaire were analyzed. Dissatisfying cosmetic results were reported significantly more frequently after subcuticular sutures (p < 0.05). Assessment of patient satisfaction with cosmetic outcome on a visual–analogue scale revealed significantly better results after transcutaneous skin closure than with other approaches (p < 0.05). Adverse wound healing (e.g., infections and dehiscence) was observed most frequently in the subcuticular suture group. Also, the rate of painful scars was highest with this technique. Conclusions: Transcutaneous closure with absorbable suture material seems to be the most suitable technique for closure of laparoscopic port-site incisions.

Diagnostic or operative laparoscopy as a minimally invasive procedure is one of the most common operations in gynecologic surgery. The benefits of minimally invasive surgery as opposed to the traditional open surgical approach are reduced pain, quicker return of oral intake, shorter hospitalization, and improved cosmetic results due to decreased scarring. Usually, 5-mm trocars and 10-mm optics are used. There are several methods for skin closure of trocar wounds. The choice of material is often based on a surgeon’s personal experience. The most common procedures are closure with transcutaneous or subcuticular sutures and the use of adhesive papertape. A newer alternative is the application of tissue adhesives such as octylcyanoacrylate (OCA) [10]. Most studies reporting on advantages and disadvantages of these different methods have focused on larger skin incisions for various surgical procedures [9, 11, 14, 15]. To the best of our knowledge, there are only two prospective randomized studies on cosmetic results of wound closure after laparoscopic surgery [8, 12]. These studies evaluated 3- to 20-mmlong port-site incisions at multiple locations (e.g., umbilical, lateral, flank, and posterior), thus reporting only relatively low numbers of 5-mm abdominal portsite closures in which a uniform/consistent method of wound closure was applied (n = 22 and n = 23, respectively). The objective of our prospective randomized trial was to assess the impact of subcuticular or transcutaneous suture of 5-mm port-site incisions or closure with adhesive papertape on potential complications of wound healing, cosmetic outcome, and patient satisfaction.

Key words: Laparoscopy — Port site incisions — Cosmetic outcome Patients and methods

Correspondence to: O. Buchweitz

From October 2002 to September 2003, 60 patients undergoing elective laparoscopic surgery were enrolled in this prospective, randomized, single-center trial. Detailed informed consent was obtained from all

149 patients preoperatively. Patients undergoing laparoscopic surgery with at least two 5-mm ports in the lower abdomen and lacking previous abdominal operations were included in the study. Exclusion criteria included intraoperative enlargement of port sites for intact specimen extraction. Patients were randomized by means of a blind envelope system just before surgery. For the laparoscopy, a 10-mm trocar (Karl Storz GmbH, Tuttlingen, Germany) was introduced through the umbilicus. Then a 5-mm port (Karl Storz) was inserted suprapubically in the pubic hairline. The second 5-mm port was placed in one of the iliac fossa just lateral to the deep inferior epigastric vessels, either on the left or on the right side depending on the medical indication. If necessary, a third port was placed analogously on the contralateral side. Wound closure of the medial incision was performed either as an interrupted transcutaneous suture or subcuticularly with absorbable sutures (4–0 polyglactin 910; Ethicon, Norderstedt, Germany) according to randomization prior to surgery. The second incision was closed using the other suture method. In the case of a third trocar, closure of this wound was performed by applying adhesive papertape (Steri-Strip; 3M Health Care, St. Paul, MN, USA). The umbilical wound was closed in the facial layer with 2–0 polyglactin 910 suture and superficially with two transcutaneous stitches using 4–0 polyglactin 910. Wounds and port sites were dressed with identical opaque dressings regardless of the surgical procedure. Postoperatively in-hospital complications regarding wound healing were recorded along with hospital stay. All patients were asked not to remove suture material. Patients were sent a questionnaire before the second follow-up at 3 months to assess satisfaction with the cosmetic results, postoperative pain at port sites, wound infections, and any other adverse wound events. To facilitate a comparison between different wound closure techniques, patients were asked to judge the cosmetic results of the scar of each port site on a visual–analogou scale (0 = totally satisfied, 10 = totally dissatisfied). According to Guyuron and Vaughan [5], scar spread was indicated at widths greater than 1 mm. Any raised scar was labeled hypertrophic. Wound infection had to be treated locally and wound redness had to persist for more than 3 months. All complications were confirmed by a physician. To avoid potential bias due to varying body mass indices, skin quality, and personality among different patients, obtained data for at least two differently closed port sites were compared only with respect to each individual patient. According to our experience and data from the literature [6, 12], complication rates after laparoscopic wound closure vary between 3 and 35%. This prospective study was designed to include 44 incisions in each arm using an error margin of ba = 0.05 for two-sided test and a power of 0.8 (b = 0.2) to prove superiority of 20% of one or the other suturing technique. However, the study was designed to include 60 patients to compensate for dropouts. Reproducible data concerning patient satisfaction with skin closure are not available. For statistical analysis, the Wilcoxon rank sum test was used for continuous variables and the chi-square McNemar test for categorical variables. The level of significance was p £ 0.05.

Results Of 60 eligible patients, 52 returned the questionnaire (86.7%). Mean age of patients was 33 ± 6.7 years. Table 1 lists the different indications for laparoscopic surgery in this series. The most common indication was endometriosis. Results of patients’ subjective satisfaction with cosmetic results with respect to different closure techniques at 3-months follow-up are shown in Table 2. Dissatisfying cosmetic results were reported significantly more frequently after subcuticular suturing of port-site incisions compared to the transcutaneously sutured wounds (p = 0.039). The number of reported dissatisfying cosmetic results was also higher after subcuticular suture of wounds than after use of adhesive papertape (not significant). Accordingly, assessment of patient satisfaction with cosmetic outcome on a linear

Table 1. Indications for laparoscopic surgery

Indication

No. of operations

Endometriosis Sterility Adhesions Ovarian cysts Hysterectomy Sterilization

22 16 5 5 2 2

visual-analogue scale revealed significantly better results after transcutaneous skin closure than with the subcuticular or the papertape approach: Out of a best score of 0, patients’ mean subjective appearance of the scar was 1.9 for the transcutaneous suture group and 2.69 and 2.44 for the subcuticular suture and the adhesive papertape group, respectively (transcutaneous vs subcuticular suture, p = 0.005; transcutaneous suture vs adhesive papertape, p = 0.048). No significant difference was observed between subcuticular suture and adhesive papertape. Each patient was considered as her own control. Adverse wound outcomes (wound infections, wound dehiscence, and persistent rubor) were also observed most frequently in subcuticular sutured port sites compared to transcutaneous closure (p = 0.039) (Table 3). No significant difference was observed between the adhesive papertape group and the groups with transcutaneous or subcuticular sutures. The rate of painful scars at follow-up was also highest in the subcuticular suture group, although this correlation was not statistically significant (Table 3).

Disussion Transcutaneous suture of laparoscopic port sites has been the standard procedure for wound closure for a long time [12]. Since absorbable sutures have been developed, subcuticular suturing of laparoscopic skin incisions has become more popular [4, 13]. Due to the additional work and expense for removal of nonabsorbable sutures, most surgeons prefer the use of absorbable material. Guyuron and Vaughan [5] and Gabel et al. [4] found no differences with respect to wound infection, wound dehiscence, persistent rubor, and development of hyperplastic scars/keloid between the applications of absorbable versus nonabsorbable sutures in intradermal repair. This is the first prospective randomized trial to compare transcutaneous and subcuticular wound closure of laparoscopic port sites using absorbable sutures for both methods. To allow an accurate comparison between the two techniques of wound closure (subcuticular vs trancutaneous sutures), we intentionally used the same suture material for both techniques to exclude a potential bias (e.g., due to different times until absorption of filaments). Polydioxanone sutures would have been a potential alternative for polyglactin. How-

150 Table 2. Follow-up data on patient satisfaction with scars

Dissatisfying cosmetic result Subjective assessment of cosmetic result (VAS) (mean ± SD)

Subcutanous suture (n = 52)

Transcutanous suture (n = 52)

Adhesive papertape (n = 23)

8 (15.4%)a 2.69 ± 2.03b

1 (1.9%) 1.90 ± 1.32

2 (8.7%) 2.44 ± 1.16b

VAS visual–analogue scale, with 0 representing the best and 10 the worst expected appearance of the scar a Statistically significant difference: subcuticular versus transcutaneous sutures (McNemar test; p < 0.05) b Statistically significant difference: subcuticular versus transcutaneous sutures (Wilcoxon rank test; p < 0.05)

Table 3. Complications of wound healing and self-reported pain of scars

Complications, total Wound infection Wound dehiscence Persistent rubor Pain of scars a

Subcutanous suture (n = 52)

Transcutanous suture (n = 52)

Adhesive papertape (n = 23)

9 (17.3%)a 4 2 3 4 (7.7%)

2 (3.8%) 1 0 1 1 (1.9%)

3 (13.0%) 1 1 1 0

Statistically significant difference: subcuticular versus transcutaneous sutures (McNemar test; p < 0.05)

ever, we decided to use polyglactin since it has the advantage of being absorbed faster. Bourne et al. [1] demonstrated that the in vivo half-life tensile strength of the braided absorbable sutures polyglycolic acid (Dexon plus) and polyglactin 910 (Vicryl) is 2 weeks, whereas those of the monofilament absorbable sutures polyglyconate (Maxon) and polydioxanone (PDS) are 3 and 6 weeks, respectively. The use of braided material for transcutaneous closure may potentially increase the risk of bacterial infections. Since our study included patients undergoing elective laparoscopies with clean wound margins and therefore a low risk of contamination, the absolute risk of bacterial infections was considered to be negligible. We noted only one wound infection (1.9%) within 52 trocar incisions for transcutaneous closure. We focused on patient satisfaction with cosmetic results of differently closed wounds. Therefore, an important inclusion criterion was the lack of previous operations in the lower abdominal region since wound healing in the area of preexisting scars is not suitable for an exact comparison with intact skin texture. To date, only two prospective randomized studies have investigated different methods of wound closure of laparoscopy port-site incisions [8, 12]. These studies both evaluated heterogeneous series concerning localization and length of port-site incisions. Thus, the number of 5-mm port-site incisions is relatively low (n = 22 [12] and n = 23 [8], respectively). Similar to our study, Rosen et al. [12] compared the subcuticular and transcutaneous suture techniques with adhesive strips for skin closure. However, in that series nonabsorbable monofilament nylon suture was used for the transcutaneous technique. The absorbable sutures applied for subcuticular closure only differed with respect to thickness, Rosen et al. used 3–0 polyglactin sutures compared to the 4–0 sutures in our study. Another difference is that after withdrawal of the laparoscopic ports a local

anesthetic was injected into the subcuticular layers at each port site. As a result, significantly less pain from wounds closed by the subcuticular technique than those closed by either transcutaneous suture or adhesive strips was reported. There was no statistically significant difference in the rate of complications or patient satisfaction between subcuticular and transcutaneous wound sites, although complications in subcuticularly sutured wounds (7/22) were more frequent compared with transcutaneously closed 5-mm port-sites (1/16). Rosen et al. concluded that, particularly because of reduced pain and similar cosmetic results, the subcuticular closure methods should be used after elective laparoscopic procedures. However, it should be noted that both Rosen et al.’s study and our data indicate a remarkably increased rate of complications after subcuticular closure. This result is interesting since transcutaneous sutures are supposed to provide an easy entry for skin pathogens compared to subcuticular methods without skin stitches. However, must be considered that both studies deal with elective laparoscopies and clean wound margins. The rate of infection in operations carrying no inherent risk of contamination has been reported to be 2 or 3% [6]. The second prospective randomized study evaluated the benefits of using the tissue adhesive octylcyanoacylate (OCA) in comparison with subcuticular sutures on closure time for laparoscopic port-site incisions [8]. This study demonstrated that closure of laparoscopic wounds is feasible with OCA and that the time to close was significantly faster for OCA in cases involving three or more port sites (median, 2.5 vs 6 min) and for cases with total length of incisions >4 cm (median, 2.6 vs 7 min). OCA and subcuticular sutures showed an equivalent wound outcome and patient acceptance rate. However, a disadvantage of this study is the lack of an internal control since only one method was applied per patient.

151

Our main finding of better cosmetic results after transcutaneous compared to subcuticular wound closure is speculative, but it may be attributed to a better adaptation of skin margins. Although a tension-free adaptation of port-site incisions in the lower abdomen is usually possible, postoperatively these incisions may be exposed to an increased mechanic irritation. This in turn may have a major impact on healing of subcuticularly sutured wounds that do not provide a direct occlusion of the superficial skin layers. The potential bias of different localizations of port sites on wound healing was excluded by the randomized use of closure techniques and standardized positions of port-site incisions. With respect to our data, alternative use of adhesive papertape for closure of laparoscopic port sites is also suitable since an equal complication rate and only slightly more dissatisfying cosmetic results were observed. The exclusive use of adhesive papertape for wound closure may conflict with the patients’ desire to shower at the soonest possible time postoperatively. In this case, OCA would be an alternative, although it is not cost-effective in most diagnostic or operative laparoscopies with two or more port-site incisions. The costs for OCA add up to $20 per 0.5 ml versus $1 per suture (4–0 Vicryl, Ethicon) [8]. Our data represent the cosmetic status 3 months after surgery and may not reflect the long-term outcome since further maturation of the scars will occur. However, the choice of this time point (3 months after surgery) for evaluation of cosmetic outcome results from our attempts to find a representative compromise between the assessment of acute wound healing (within the first postoperative days) and completed wound healing. In the literature, evaluation of outcome of wound healing usually takes place between 1 week and 1–6 months after surgery [2, 3, 7, 8, 12]. There are no data on the time-dependent long-term course of the maturation of scars. The optimal time point for evaluation of scars is not clear. Wound closure using all three methods in the same patient was performed in only a smaller subset of patients (23 of 52). Thus, the significance of comparing wound closure with adhesive papertape versus wound closure using sutures (eligible in 23 patients) may be minor in comparison with statistical calculation of the two different suture methods (eligible in 52 patients). In conclusion, we observed a significantly higher percentage of satisfying cosmetic results and a reduced rate of complications with transcutaneous compared to subcuticular sutures of laparoscopic wounds. Moreover,

the use of absorbable suture material for both transcutaneous and subcuticular sutures has the advantage of not requiring further visits for removal, which is an important economic consideration, especially for day surgeries. According to our findings, we can thus clearly recommend the transcutaneous technique with absorbable sutures for wound closure of 5-mm port-site incisions. As an alternative to polyglactine 910, irradiated polyglactin 910/370 as a more rapidly dissolving material may be useful. Further studies should be performed.

References 1. Bourne RB, Bitar H, Andreae PR, Martin LM, Finlay JB, Marquis F (1988) In- vivo comparison of four absorbable sutures: Vicryl, Dexon Plus, Max on and PDS. Can J Surg 31: 43–45 2. Chen HH, Tsai WS, Yeh CY, Wang JY, Tang R (2001) Prospective study comparing wounds closed with tape with sutured wounds in colorectal surgery. Arch Surg 136: 801–803 3. Frishman GN, Schwartz T, Hogan JW (1997) Closure of Pfannenstiel skin incision. Staples vs subcuticular suture. J Reprod Med 42: 627–630 4. Gabel EA, Jimenez GP, Eaglstein WH, Kerdel FA, Falanga V (2000) Performance comparison of nylon and a absorbable suture material (polyglactin 910) in the closure of punch biopsy sites. Dermatol Surg 26: 750–753 5. Guyuron B, Vaughan C (1992) A comparison of absorbable and nonabsorbable suture materials for skin repair. Plastic Reconstr Surg 89: 234–236 6. Irvin TT (1985) Simple skin closure. Br J Hosp Med 33: 325–330 7. Lundblad R, Simensen HV, Wiig JN, Niels Gruner OP (1989) Skin closure. A prospective randomized study. Tidsskr Nor Laegeforen 109: 1307–1309 8. Matin SF (2003) Prospective randomized trial of skin adhesive versus sutures for closure of 217 laparoscopic port-site incisions. J Am Coll Surg 196: 845–853 9. Pedersen VM, Jensen BS, Hansen B (1981) Skin closure in abdominal incisions. Acta Chir Scand 147: 619–622 10. Quinn J, Wells G, Sutcliffe T, et al. (1998) Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcomes. Ann Emerg Med 32: 645–664 11. Ralphs DNL, Cannon SR, Bolton JP (1982) Skin closure of inguinal herniorrhaphy wounds in short-stay patients. Br J Surg 69: 341–342 12. Rosen DM, Carlton MA (1997) Skin closure at laparoscopy. J Am Assoc Gynecol Laparosc 4: 347–351 13. Serour F, Efrati Y, Klin B, Barr J, Gorenstein A, Vinogard I (1998) Subcuticular skin closure as a standard approach to emergency appendectomy in children: prospective clinical trial. Word J Surg 20: 38–42 14. Stillmann RM, Bella FJ, Seligman SJ (1980) Skin wound closure. Arch Surg 115: 674–675 15. Winn HR, Jane JA, Rodeheaver G (1977) Influence of subcuticular sutures on scar formation. Am J Surg 133: 257–259