STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

Last updated: March 18, 2025
Sponsor: Third Military Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Surgery

Treatment

total colectomy with ileorectal anastomosis

subtotal colectomy with cecal-rectal anastomosis

Total colectomy with ileorectal anastomosis

Clinical Study ID

NCT05352074
20211114
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

Inclusion criteria

  1. Patients (≥18 years of age) of either sex

  2. Patients with conditions in agreement with the Roman IV criteria of functional constipation

  3. Patients have less than one complete spontaneous bowel movement per week

  4. Patients rely on laxatives to assist defecation for a long time

  5. More than 20% the radio-paque markers localized in the colon after 72 hours based on colonic transit studies

  6. Patients were refractory to conservative treatment for more than 1 year

  7. Patients with a strong desire for surgery

Exclusion criteria

  1. Pregnant or breast-feeding women

  2. Patients with megacolon, megarectum,severe spastic constipation, severe rectocele, rectal prolapse (Oxford Grade IV or above)

  3. Patients with colorectal neoplasms

  4. Patients with small intestinal slow transit

  5. Patients with constipation-predominant irritable bowel syndrome

  6. Patients with inflammatory bowel disease

  7. Patients with ileostomy

  8. Patients with severe psychiatric disease

Study Design

Total Participants: 252
Treatment Group(s): 4
Primary Treatment: total colectomy with ileorectal anastomosis
Phase:
Study Start date:
March 27, 2022
Estimated Completion Date:
December 31, 2028

Study Description

Constipation, a prevalent gastrointestinal disorder, affects 10%-15% of adults in the United States and approximately 8.2% of China's general population. Slow transit constipation (STC), accounting for 15%-42% of constipation cases, is characterized by impaired colonic motility. For patients refractory to conservative therapies who experience chronic, intractable symptoms and diminished quality of life (QoL), surgical intervention becomes the last-resort treatment. The primary surgical approach for STC has historically been total colectomy with ileorectal anastomosis (TC-IRA). Over the past two decades, however, subtotal colectomy with cecorectal anastomosis (SC-CRA) has garnered growing interest within the surgical community due to its potential to mitigate postoperative diarrhea. Despite this benefit, SC-CRA raises concerns about an elevated risk of recurrent constipation. The debate regarding the superiority of these approaches remains unresolved. This study aims to address this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC.

Connect with a study center

  • Army Medical Center

    Yuzhong, Chongqing 400042
    China

    Active - Recruiting

  • Army Medical Center (Daping Hospital)

    Yuzhong, Chongqing 400042
    China

    Active - Recruiting

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

    Lanzhou, Gansu 730050
    China

    Active - Recruiting

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

    Lanzhou, Gansu 730050
    China

    Active - Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi 530016
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Ha'erbin, Heilongjiang 150007
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430062
    China

    Active - Recruiting

  • General Hospital of the Eastern Theater Cammand of the PLA

    Nanjing, Jiangsu 210002
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shengyang, Liaoning 110001
    China

    Active - Recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266011
    China

    Active - Recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Pudong, Shanghai 200127
    China

    Active - Recruiting

  • Renji Hospital, Shanghai Jiaotong University

    Pudong, Shanghai 200127
    China

    Active - Recruiting

  • Shanghai Pudong New Area People's Hospital

    Pudong, Shanghai 201299
    China

    Active - Recruiting

  • Xi-Jing Hospital

    Xi'an, Shanxi 710032
    China

    Active - Recruiting

  • Xijing Hospital

    Xi'an, Shanxi 710032
    China

    Active - Recruiting

  • Chengdu Analrectal Hospital

    Chengdu, Sichuan 610017
    China

    Active - Recruiting

  • The General Hospital of Western Theater Command

    Chengdu, Sichuan 610036
    China

    Active - Recruiting

  • The Second People's Hospital of Yibin

    Yibin, Sichuan 644000
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Active - Recruiting

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