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Trial Title:
Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy
NCT ID:
NCT06344923
Condition:
Ileostomy - Stoma
Rectal Neoplasms
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing
Description:
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.
Arm group label:
modified preventive ileostomy
Intervention type:
Procedure
Intervention name:
Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing
Description:
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
Arm group label:
conventional preventive ileostomy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- preventive ileostomy in laparoscopic rectal surgery
Exclusion Criteria:
- ileostomy due to anastomotic leak
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiang Zhang
Phone:
+8618560089182
Email:
xiang.zhang02@hotmail.com
Investigator:
Last name:
Xiang Zhang, M.D. Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Yanlei Wang, M.D. Ph.D
Email:
Sub-Investigator
Start date:
May 14, 2024
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06344923
