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Suture Techniques to Reduce the Incidence of Incisional Hernia: LTFU STITCH Trial (LTFU-STITCH)

Primary Purpose

Surgery, Incisional Hernia, Wound Infection

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Small bites technique
Conventional large bites closure
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Surgery, Incisional Hernia, Wound Infection, Fascial Dehiscence, Pain, Quality of Life, Pathological Conditions, Anatomical, Infections, Postoperative Complications, Pathologic Processes

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

In order to be eligible to participate in this study, a subject must meet the following criteria: Available signed informed consent form for the original STITCH trial of the patients who are still alive. Or if the patients has died, the medical records are reviewed. A potential subject who meets the following criteria will be excluded from participation in this study: - Patients that on the original informed consent form of the STITCH trial, checked the box that they did not want to be approached for future follow-up studies.

Sites / Locations

  • Erasmus MCRecruiting
  • Meander Medical CenterRecruiting
  • Rijnstate ziekenhuisRecruiting
  • Red Cross HospitalRecruiting
  • Groene Hart ZiekenhuisRecruiting
  • Spaarne GasthuisRecruiting
  • Franciscus Gasthuis & VlietlandRecruiting
  • Prior Havenziekenhuis patients currently in the Erasmus MCRecruiting
  • Elisabeth-TweeSteden ZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Small bites suturing technique of the abdominal wall during midline laparotomy

Large bites suturing technique of the abdominal wall during midline laparotomy

Arm Description

In the experimental group of 288 patients the small bites technique was applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.

As control the conventional large bites technique (mass closure) was applied with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.

Outcomes

Primary Outcome Measures

Incisional hernia occurrence (and timeto incisional hernia outcome).
Incisional hernia occurrence after operation clinical and/or radiological diagnosis.

Secondary Outcome Measures

Quality of life of the patient.
Quality of life measured by MOS SF-36, ranging from 0 (worst) to 100 (best).
Quality of life of the patient.
Quality of life measured by and EQ-5D, ranging from 0 (worst) to 100 (best).
Body image.
Body image measured by Dresden Body Image Questionnaire (DBIQ), consisting of 35 questions that can be answered with a yes or no. This results in a range of 0 (worst) to 35 (best) points.
Cosmetic results, cosmesis.
Cosmetic results measured by Body Image Questionnaire (BIQ), consisting of 10 questions with a score ranging from 10 (worst) to 64 (best) points.
AWF.
Hernia-Related Quality of Life Survey (HerQLes), with 12 questions ranging from 12 (worst) to 72 (best) points.

Full Information

First Posted
September 1, 2023
Last Updated
September 27, 2023
Sponsor
Erasmus Medical Center
Collaborators
Franciscus &Vlietland, Elisabeth-TweeSteden Ziekenhuis, Rijnstate Hospital, Spaarne Gasthuis, Meander Medisch Centrum, Red Cross Hospital Beverwijk
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1. Study Identification

Unique Protocol Identification Number
NCT06066385
Brief Title
Suture Techniques to Reduce the Incidence of Incisional Hernia: LTFU STITCH Trial
Acronym
LTFU-STITCH
Official Title
Suture Techniques to Reduce the Incidence of Incisional Hernia After Midline Laparotomy; Long-Term Follow-Up of the STITCH Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Franciscus &Vlietland, Elisabeth-TweeSteden Ziekenhuis, Rijnstate Hospital, Spaarne Gasthuis, Meander Medisch Centrum, Red Cross Hospital Beverwijk

4. Oversight

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

5. Study Description

Brief Summary
Rationale: Incisional hernias (IH) are a frequent complication after abdominal surgery. Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70% in high-risk patients after open surgery. To investigate different fascia closure techniques in the prevention of IHs, the STITCH trial (NCT01132209) was designed. The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy. Patients were randomly assigned to the intervention group (small bites 5 mm x 5 mm) or the control group (large bites 1 cm x 1 cm). The study showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision. So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group. Objective: The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.
Detailed Description
Rationale: Incisional hernias (IH) are a frequent complication after abdominal surgery. Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70% in high-risk patients after open surgery. To investigate different fascia closure techniques in the prevention of IHs, the STITCH trial (NCT01132209) was designed, a randomized controlled trial in which 560 patients were included between October 2009 and March 2012. The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy. Patients were randomly assigned to the intervention group (small bites 5 mm x 5 mm) or the control group (large bites 1 cm x 1 cm). It showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision. So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group. Objective: The primary objective of this study study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive. Study design: Assessment of long-term follow-up (10-13 years) of a randomized controlled multicenter study based on retrospective review of patient files and relevant imaging of the entire trial population, as well as questionnaires and physical and radiological examination of patient who are still alive. Study population: Of the 560 included patients in the original STITCH trial, 545 completed the 1-year follow-up. Intervention (if applicable): Not applicable. Main study parameters/endpoints: The primary outcome measure is the 10-year midline incisional hernia rate. The primary endpoint will be determined for the 545 patients of the original intention-to-treat population using Kaplan Meier analysis. In patients who died during follow-up, this will be evaluated by reviewing the available medical charts and radiological studies. CT-scans of the abdomen will be evaluated by the study-team. If CT imaging is not available, documented findings during physical examination by the relevant medical specialist will be considered. Patients being still alive with written informed consent to be contacted will be approached for their willingness to participate in this follow-up study, and after consent, we will reassess CT scans for an incisional hernia. All patients who are still alive and want to participate in this study will be asked to visit the hospital once for physical examination and an ultrasound of the abdominal wall. Secondary outcome parameters include QoL and cosmetic outcome, Patients still alive with consent for participation will be sent the following questionnaires: MOS SF-36 and EQ-5D (QoL), Dresden Body Image Questionnaire (body image), Body Image Questionnaire (cosmesis), Hernia-Related Quality of Life Survey (abdominal wall function). Furthermore, readmission and surgical intervention rates related to midline IH will be determined for the entire study population. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Undergoing an ultrasound, physical examination and completing several questionnaires may be considered burdensome for the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Incisional Hernia, Wound Infection, Fascial Dehiscence, Pain, Quality of Life
Keywords
Surgery, Incisional Hernia, Wound Infection, Fascial Dehiscence, Pain, Quality of Life, Pathological Conditions, Anatomical, Infections, Postoperative Complications, Pathologic Processes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Long-term follow-up with Outcome Assesor blinding of a parallel assigned double blinded (Participant, Investigator) Randomised Controlled trial
Masking
Outcomes Assessor
Masking Description
Outcome assessors of previous radiological imaging and imaging created during our Long-term follow up will be blinded to the assigned randomization arm.
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Small bites suturing technique of the abdominal wall during midline laparotomy
Arm Type
Experimental
Arm Description
In the experimental group of 288 patients the small bites technique was applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.
Arm Title
Large bites suturing technique of the abdominal wall during midline laparotomy
Arm Type
Active Comparator
Arm Description
As control the conventional large bites technique (mass closure) was applied with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.
Intervention Type
Procedure
Intervention Name(s)
Small bites technique
Intervention Description
Closure of the fascia after midline laparotomy using a slowly resorbalbe 2.0 suture, with 0.5 cm bites, and 0.5 cm between the stitches, at least resulting in a 1:4 wound length:suture length ratio.
Intervention Type
Procedure
Intervention Name(s)
Conventional large bites closure
Intervention Description
Closure of a midline laparotomy using a slowy resorbable thick suture (e.g. PDS loop) with large bites and large steps (>= 1 cm).
Primary Outcome Measure Information:
Title
Incisional hernia occurrence (and timeto incisional hernia outcome).
Description
Incisional hernia occurrence after operation clinical and/or radiological diagnosis.
Time Frame
Patients will have a follow-up of up to 12 years, with most patients having a follow-up between 10 and 12 years.
Secondary Outcome Measure Information:
Title
Quality of life of the patient.
Description
Quality of life measured by MOS SF-36, ranging from 0 (worst) to 100 (best).
Time Frame
Patients will have a follow-up of more than 10 years.
Title
Quality of life of the patient.
Description
Quality of life measured by and EQ-5D, ranging from 0 (worst) to 100 (best).
Time Frame
Patients will have a follow-up of up to 12 years.
Title
Body image.
Description
Body image measured by Dresden Body Image Questionnaire (DBIQ), consisting of 35 questions that can be answered with a yes or no. This results in a range of 0 (worst) to 35 (best) points.
Time Frame
Patients will have a follow-up of up to 12 years.
Title
Cosmetic results, cosmesis.
Description
Cosmetic results measured by Body Image Questionnaire (BIQ), consisting of 10 questions with a score ranging from 10 (worst) to 64 (best) points.
Time Frame
Patients will have a follow-up of up to 12 years.
Title
AWF.
Description
Hernia-Related Quality of Life Survey (HerQLes), with 12 questions ranging from 12 (worst) to 72 (best) points.
Time Frame
Patients will have a follow-up of up to 12 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
In order to be eligible to participate in this study, a subject must meet the following criteria: Available signed informed consent form for the original STITCH trial of the patients who are still alive. Or if the patients has died, the medical records are reviewed. A potential subject who meets the following criteria will be excluded from participation in this study: - Patients that on the original informed consent form of the STITCH trial, checked the box that they did not want to be approached for future follow-up studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rudolf van den Berg
Phone
0107043683
Email
R.vandenBerg.4@Erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah van Egmond
Phone
0107043683
Email
S.vanEgmond@Franciscus.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter J Tanis
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
State/Province
South-Holland
ZIP/Postal Code
3015
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter J Tanis, Prof.dr
Phone
003110 704 0704
Email
p.tanis@erasmusmc.nl
Facility Name
Meander Medical Center
City
Amersfoort
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Rijnstate ziekenhuis
City
Arnhem
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Red Cross Hospital
City
Beverwijk
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Spaarne Gasthuis
City
Haarlem
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Franciscus Gasthuis & Vlietland
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Prior Havenziekenhuis patients currently in the Erasmus MC
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Elisabeth-TweeSteden Ziekenhuis
City
Tilburg
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/26188742/
Description
Original STITCH trial

Learn more about this trial

Suture Techniques to Reduce the Incidence of Incisional Hernia: LTFU STITCH Trial

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