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Laparoscopic Incision Closure s in Obese Patients (LICOP)

Primary Purpose

Obesity, Incision, Surgical

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adhesive glue closure
Subcuticular closure
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria: - All women undergoing gynecologic laparoscopic surgery. Exclusion criteria: - Connective tissue disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    One abdominal side

    Second abdominal side

    Arm Description

    Arm randomized for adhesive glue closure

    Arm randomized for subcuticular suture closure

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Surgical site infection rate
    Surgical site infection rate

    Full Information

    First Posted
    November 10, 2022
    Last Updated
    May 18, 2023
    Sponsor
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05622110
    Brief Title
    Laparoscopic Incision Closure s in Obese Patients
    Acronym
    LICOP
    Official Title
    Laparoscopic Incision Closure Following Gynecological Benign Surgeries in Obese Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Laparoscopic surgery has become the standard of care for surgical procedures across multiple specialties, reducing perioperative complications, accelerating recovery and providing superior cosmetic results. Trocars are used in laparoscopic procedures to provide a portal for the placement of surgical instruments. Typically, three to four or more trocars of different sizes ranging from 5 to 15 mm in diameter are used in abdominal and pelvic surgery. Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. The skin closure method should aim to keep the skin closely opposed during the hemostatic and inflammatory healing phases until the overlapping proliferative phase is able to provide tensile strength. The choice of technique is often based on the surgeon's personal experience. and is largely dependent on training exposure and local opinion. There is currently no consensus as to the optimal method of closure of the skin following laparoscopic surgery. Previous meta-analyses examining skin closure methods for all surgical wounds have found suture to have significantly decreased rates of wound dehiscence compared to tissue adhesive. Meta-analysis published recently by Aitchison et al. compared between sutures, tissue adhesives and adhesive paper tape. They reported no difference in patient-evaluated cosmesis, prolonged pain, or patient satisfaction between the three groups. Nevertheless, no data specifically address the obese population. Port-site trocar incision closure is a challenging procedure in laparoscopic surgeries, particularly in patients with clinically severe (morbid) obesity. Complications related to port-site trocars, even if uncommon, may have severe consequences that can lead to reoperation and permanent damage Studies comparing laparoscopic incision closure in bariatric population are limited. Fecso et al conducted a retrospective cohort study including 1579 bariatric patients, of them 494 were treated with tissue adhesive for skin closure. They reported that the use of tissue adhesive was more common in patients who developed incisional surgical site infection compared with those without incisional surgical site infection (SSI) (54.3 vs. 30.8%, p = 0.003). Our department usually practice subcuticular and adhesive glue for the closure of laparoscopic incisions, based on surgeon's preference. As 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. Material and Methods This is a prospective study that will be conducted in a single tertiary medical center. Study population will include all women undergoing gynecologic laparoscopic surgery with BMI of 30 kg/m² or above. Women with connective tissue disease will be excluded from the study. Intervention: Each woman will undergo both interventions therefore will serve as her own control. All ports up to 8 mm (following robotic or conventional laparoscopy) will be eligible for inclusion in the study. The umbilicus will serve as a reference separating the right and left side incisions. Each side will be closed randomly using one of the two techniques. Randomizing the closure technique will be done based on the serial number given to each woman on recruitment (En block randomization) : Odd serial number: Right side - subcuticular suturing, Left side- adhesive glue Even numbers: Right side- adhesive glue, Left side- subcuticular suturing Incisions would be closed by one or the other following techniques: 1- Subcuticular closure- using 4-0 Monocryl suture will be used; 2- Adhesive glue (Dermabond). On follow up visit 2- and 8-weeks post operation - each woman will complete the validated Patient Scar Assessment Questionnaire (PSAQ) on follow-up at 2- and 8-weeks post operation for the right and left side of the abdomen(10). The PSAQ consists of 4 scored subscales: Appearance, Consciousness, Appearance Satisfaction, and Symptom Satisfaction. Each subscale has a set of questions with a 4-point categorical response (1=most favorable, 4=least favorable). The sum of the scores quantifies each subscale. Demographic and clinical characteristics will be collected from women's medical files. Operative and post-operative data will be collected including: operation duration, estimated blood loss, operation complications (hypotension, bladder gut or vascular perforation), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Incision, Surgical

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Masking Description
    The physician doing follow up will be masked to the type of closure in each side
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    One abdominal side
    Arm Type
    Experimental
    Arm Description
    Arm randomized for adhesive glue closure
    Arm Title
    Second abdominal side
    Arm Type
    Experimental
    Arm Description
    Arm randomized for subcuticular suture closure
    Intervention Type
    Procedure
    Intervention Name(s)
    Adhesive glue closure
    Intervention Description
    Incision closure with adhesive glue
    Intervention Type
    Procedure
    Intervention Name(s)
    Subcuticular closure
    Intervention Description
    Incision closure with 3-0 vicryl subcuticular sutures
    Primary Outcome Measure Information:
    Title
    Patient Scar Assessment Questionnaire (PSAQ)
    Description
    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
    Time Frame
    From recruitment until 8 weeks post-operation
    Secondary Outcome Measure Information:
    Title
    Surgical site infection rate
    Description
    Surgical site infection rate
    Time Frame
    From recruitment until 8 weeks post-operation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Inclusion criteria includes women undergoing bening gynecological surgeries
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: - All women undergoing gynecologic laparoscopic surgery. Exclusion criteria: - Connective tissue disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aya Mohr-Sasson, M.D
    Phone
    13462704682
    Email
    aya.mohrsasson@uth.tmc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aya Mohr-Sasson, M.D
    Organizational Affiliation
    The University of Texas Health Science Center, Houston, TX
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    36071329
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24862661
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    1535528
    Citation
    Harvey MH, Cahill J, Wastell C. Laparoscopic general surgery. Br J Hosp Med. 1992 May 6-19;47(9):655-62.
    Results Reference
    result
    PubMed Identifier
    26562746
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    15549624
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19263132
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    25431843
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    35610480
    Citation
    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.
    Results Reference
    result

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    Laparoscopic Incision Closure s in Obese Patients

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