Laparoscopic Incision Closure s in Obese Patients

NCT05622110 | Completed

• 1 other identifier: HSC-MS-22-0840
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. Studies comparing laparoscopic incision closure in bariatric population are limited .This is a prospective study that will be conducted in a single tertiary medical center. s obese population comprise most of our surgical candidates, and due to the aforementioned, the aim of our study is to compare the outcomes of both techniques in obese women.

Conditions

Obesity; Incision, Surgical

Outcome Measures

Primary Outcomes (1)

• Patient Scar Assessment Questionnaire (PSAQ)

  The difference in appearance score of the abdominal scars evaluated by the Patient Scar Assessment Questionnaire (PSAQ) between the two techniques reported by the patients at 2 and 8 weeks follow up

  From recruitment until 8 weeks post-operation

Secondary Outcomes (1)

• Surgical site infection rate

  From recruitment until 8 weeks post-operation

Study Arms (2)

One abdominal side

EXPERIMENTAL

Arm randomized for adhesive glue closure

Procedure: Adhesive glue closure

Second abdominal side

EXPERIMENTAL

Arm randomized for subcuticular suture closure

Procedure: Subcuticular closure

Interventions

Adhesive glue closure PROCEDURE

Incision closure with adhesive glue

One abdominal side

Subcuticular closure PROCEDURE

Incision closure with 3-0 vicryl subcuticular sutures

Second abdominal side

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Inclusion criteria includes women undergoing bening gynecological surgeries
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All women undergoing gynecologic laparoscopic surgery.

You may not qualify if:

• \- Connective tissue disease

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas

Houston, Texas, 77030, United States

Location

Related Publications (8)

• Andraos Y. Safety and Efficacy of Trocar Port-Site Closure Using a Biological Plug Closure in Laparoscopic Bariatric Surgery: a Prospective Study. Obes Surg. 2022 Nov;32(11):3796-3806. doi: 10.1007/s11695-022-06238-y. Epub 2022 Sep 7.

  PMID: 36071329 BACKGROUND

• Pilone V, Di Micco R, Hasani A, Celentano G, Monda A, Vitiello A, Izzo G, Iacobelli L, Forestieri P. Trocar site hernia after bariatric surgery: our experience without fascial closure. Int J Surg. 2014;12 Suppl 1:S83-6. doi: 10.1016/j.ijsu.2014.05.047. Epub 2014 May 23.

  PMID: 24862661 BACKGROUND

• Harvey MH, Cahill J, Wastell C. Laparoscopic general surgery. Br J Hosp Med. 1992 May 6-19;47(9):655-62.

  PMID: 1535528 RESULT

• Qian LW, Fourcaudot AB, Yamane K, You T, Chan RK, Leung KP. Exacerbated and prolonged inflammation impairs wound healing and increases scarring. Wound Repair Regen. 2016 Jan-Feb;24(1):26-34. doi: 10.1111/wrr.12381. Epub 2016 Jan 12.

  PMID: 26562746 RESULT

• Buchweitz O, Wulfing P, Kiesel L. A prospective randomized trial of closing laparoscopic trocar wounds by transcutaneous versus subcuticular suture or adhesive papertape. Surg Endosc. 2005 Jan;19(1):148-51. doi: 10.1007/s00464-004-9043-2. Epub 2004 Nov 18.

  PMID: 15549624 RESULT

• Sajid MS, Siddiqui MR, Khan MA, Baig MK. Meta-analysis of skin adhesives versus sutures in closure of laparoscopic port-site wounds. Surg Endosc. 2009 Jun;23(6):1191-7. doi: 10.1007/s00464-009-0373-y. Epub 2009 Mar 5.

  PMID: 19263132 RESULT

• Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.

  PMID: 25431843 RESULT

• Aitchison LP, Chen AZL, Toms C, Sandroussi C, Yeo DA, Steffens D. To stitch or not to stitch: the skin closure of laparoscopic port sites, a meta-analysis. Surg Endosc. 2022 Oct;36(10):7140-7159. doi: 10.1007/s00464-022-09269-9. Epub 2022 May 24.

  PMID: 35610480 RESULT

MeSH Terms

Conditions

Obesity; Surgical Wound

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Aya Mohr-Sasson, M.D

  The University of Texas Health Science Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The physician doing follow up will be masked to the type of closure in each side
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 18, 2022
• Study Start: December 2, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)