RecruitingNot ApplicableNCT05352074

STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

STOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy With Ileorectal Anastomosis Versus Subtotal Colectomy With Cecal-rectal Anastomosis for Slow Transit Constipation


Sponsor

Third Military Medical University

Enrollment

252 participants

Start Date

Mar 27, 2022

Study Type

INTERVENTIONAL

Summary

Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • Patients (≥18 years of age) of either sex
  • Patients with conditions in agreement with the Roman IV criteria of functional constipation
  • Patients have less than one complete spontaneous bowel movement per week
  • Patients rely on laxatives to assist defecation for a long time
  • More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies
  • Patients were refractory to conservative treatment for more than 1 year
  • Patients with a strong desire for surgery

Exclusion Criteria8

  • Pregnant or breast-feeding women
  • Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)
  • Patients with colorectal neoplasms
  • Patients with small intestinal slow transit
  • Patients with constipation-predominant irritable bowel syndrome
  • Patients with inflammatory bowel disease
  • Patients with ileostomy
  • Patients with severe psychiatric disease

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Interventions

PROCEDURETotal colectomy with ileorectal anastomosis

Following complete colonic mobilization without preservation of the ileocolic vascular pedicle, the surgical specimen was extracted by extending the right lower quadrant trocar incision to approximately 4-5 cm. A resection of ileum, 2-3 cm proximal to the ileocecal junction, will be conducted by stapler. The anvil of a 29-mm circular stapler was inserted into the proximal ileal lumen and repositioned intra-abdominally. Ileorectal anastomosis was performed by transanal insertion of the circular stapler, aiming to achieve a tension-free, contamination-minimized reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in layers.

PROCEDURESubtotal colectomy with cecal-rectal anastomosis

Following complete colonic mobilization with preservation of the ileocolic vascular pedicle and its branches, the surgical specimen was extracted by extending the right lower quadrant trocar incision to 4-5 cm. After insertion of the anvil from a 29-mm circular stapler through the ascending colon resection margin, a resection about 3 cm distal to the ileocecal junction will be conducted. The cecum was then positioned in the pelvis without rotational torsion, and an antiperistaltic cecorectal anastomosis was created between cecal fundus (after appendectomy) and the rectal stump. The anastomosis was performed via transanal insertion of the circular stapler to ensure tension-free, contamination-controlled reconstruction. Finally, a closed suction drain was placed in the rectouterine pouch (Douglas pouch), and all abdominal incisions were closed in a layered fashion.


Locations(16)

Army Medical Center (Daping Hospital)

Yuzhong, Chongqing Municipality, China

No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army

Lanzhou, Gansu, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

General Hospital of the Eastern Theater Cammand of the PLA

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shengyang, Liaoning, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Renji Hospital, Shanghai Jiaotong University

Pudong, Shanghai Municipality, China

Shanghai Pudong New Area People's Hospital

Pudong, Shanghai Municipality, China

Xijing Hospital

Xi’an, Shanxi, China

Chengdu Analrectal Hospital

Chengdu, Sichuan, China

The General Hospital of Western Theater Command

Chengdu, Sichuan, China

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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NCT05352074