Comparison of Robot-assisted With Laparoscopic-assisted Modified Soave Procedure for Classical Hirschsprung Disease

Summary

Hirschsprung disease (HSCR) is a rare congenital intestinal disease characterized by the absence of ganglion cells in the distal rectum, extending for variable distances into the proximal intestine.The \"pull-through\" reconstruction procedure described in 1949 by Orvar Swenson involving the removal of the aganglionic bowel and creating an anastomosis between the normally innervated bowel and the anal canal, remains the standard surgical approach for HSCR today. However, as rectal dissection by laparotomy in infants is technically difficult and can result in high rates of complications, other pull-through techniques were developed and several techniques are still widely used today.

In our institute, we developed the laparoscopic-assisted modified Soave with short muscular cuff anastomosis in July 2017, and achieved good therapeutic effects. However, there have some patients suffered soiling incidents in the short period post-surgery.

Therefore, we developed the robot-assisted modified Soave with short muscular cuff anastomosis procedures to protect the vital nerve and blood vessels of the pelvis from injury, decrease the injury of the sphincter.

this clinical trials was to compare the efficacy of robot-assisted and laparoscopic-assisted modified Soave with short muscular cuff anastomosis procedures for classical Hirschsprung disease (HSCR).

Conditions

• Hirschsprung Disease

Interventions

PROCEDURE

RAMS

The robotic arms were oriented from the caudal direction. Dissection was begun circumferentially at 1.0 cm above the peritoneal reflection. The rectum was mobilized outside the longitudinal muscle layer, with the anatomical plane farther away from Denonvillier's fascia and the nerve plexus anterior or lateral to the rectum. The mobilization of the rectum reached 4-7 cm into the pelvis. After the robot was unlocked, a circular incision was made 0.5-1 cm from the dentate line, dividing the mucosa upward by 0.5-1.0 cm, breaking through the muscular cuff, and exposing the robotic dissection plane in the pelvis. The diseased colon was then gently pulled out through the anus. The posterior wall of the muscular cuff was completely removed along the left and right sides, accounting for two-thirds of the whole circular muscular cuff to 0.5 cm of the dentate line edge. One third of the anterior wall of the muscular cuff was retained,we then performed Soave's anastomosis.

PROCEDURE

LAMS

The mesentery of the colon was separated by laparoscopy with the vessel of the pull-through bowel preserved. Under the rectal peritoneal reflex, close to the rectal wall separate with the electric hook, the anterior wall of the rectum was separated to the bladder neck or the posterior wall of the vagina. The posterior wall of the rectum can be separated down to 1cm above the dentate line. After the laparoscopy was unlocked, a circular incision was made 0.5-1 cm from the dentate line, dividing the mucosa upward by 0.5-1.0 cm, breaking through the muscular cuff, and exposing the laparoscopic dissection plane in the pelvis. The diseased colon was then gently pulled out through the anus. The posterior wall of the muscular cuff was completely removed along the left and right sides, accounting for two-thirds of the whole circular muscular cuff to 0.5 cm of the dentate line edge. One third of the anterior wall of the muscular cuff was retained,we then performed Soave's anastomosis.

Sponsors & Collaborators

• Zunyi Medical College

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-07

Primary Completion

2024-02-08

Completion

2024-10-10

Countries

• China

Study Locations