Clinical Trials Logo
  1. Home
  2. Rectal Neoplasms
  3. NCT06344923
  4. Details
NCT06344923 Clinical Trial

Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

Rectal Neoplasms Clinical Trial

Official title:
Does Suturing the Peritoneum and Anterior Rectus Sheath Affect the Safety of Temporary Loop Ileostomy After Laparoscopic Anterior Rectal Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06344923
Other study ID # KYLL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date September 1, 2025

Study information
Verified date March 2024
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date September 1, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - preventive ileostomy in laparoscopic rectal surgery Exclusion Criteria: - ileostomy due to anastomotic leak

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing
The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. A support rod, made of a 24# silicone drainage tube with a 1ml syringe was passed through the mesentery of the small intestine. The support rod was removed two weeks after surgery. It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches.
• Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing
The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. The seromuscular layer of the ileum or the mesentery was intermittently sutured with peritoneum and the anterior sheath of the rectus abdominis circumferentially with 8-10 stitches (3-0 silk thread). It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative complications related to ileostomy after primary surgery to ileostomy closure (6 months after primary surgery)
See also
  Status Clinical Trial Phase
Completed NCT02537340 - PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
Recruiting NCT02565667 - A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler N/A
Terminated NCT02538913 - Exercise Training for Rectal Cancer Patients N/A
Not yet recruiting NCT02439086 - Prediction of Response to Neoadjuvant Therapy in Rectal Cancer N/A
Completed NCT02233374 - Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
Completed NCT00535041 - Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA N/A
Recruiting NCT04949646 - Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision N/A
Recruiting NCT04095468 - Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
Recruiting NCT06017583 - Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer Phase 3
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT04006951 - Development of a Clinical and Biological Database in Rectum Cancer N/A
Recruiting NCT05068180 - Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients Phase 4
Recruiting NCT03714490 - MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer Phase 2
Recruiting NCT03325361 - The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage N/A
Completed NCT02252250 - Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer N/A
Completed NCT04455737 - Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Completed NCT01816607 - Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Completed NCT01721785 - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer N/A
Active, not recruiting NCT01171300 - Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients N/A