Clinical trial NCT05352074: STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Slow Transit Constipation
Surgery
Keywords: Slow Transit Constipation
Total Colectomy with Ileorectal Anastomosis
Subtotal Colectomy with Caecorectal Anastomosis
Defecation Function
Quality of Life
Randomized Controlled Trial
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Wexner Constipation Score
timeFrame: From the pre-operation to 36 months following surgery
Secondary outcomes:
measure: Gastrointestinal Quality of Life Index
timeFrame: From the pre-operation to 36 months following surgery
measure: 36-item short-form health survey
timeFrame: From the pre-operation to 36 months following surgery
measure: The incidence of complications
timeFrame: From the pre-operation to 36 months following surgery
measure: The number of bowel movements per week
timeFrame: From the pre-operation to 36 months following surgery
measure: Wexner's incontinence score
timeFrame: From the pre-operation to 36 months following surgery
measure: The incidence of abdominal pain
timeFrame: From the pre-operation to 36 months following surgery
measure: The incidence of bloating
timeFrame: From the pre-operation to 36 months following surgery
measure: The incidence of diarrhea
timeFrame: From the pre-operation to 36 months following surgery
measure: The incidence of straining
timeFrame: From the pre-operation to 36 months following surgery
measure: The incidence of laxative use
timeFrame: From the pre-operation to 36 months following surgery
measure: The incidence of enema use
timeFrame: From the pre-operation to 36 months following surgery
measure: Intraoperative measures
timeFrame: Perioperative period
Other outcomes:
Locations:
city: Yuzhong
country: China
facility: Army Medical Center (Daping Hospital)
state: Chongqing
city: Lanzhou
country: China
facility: No. 940 Hospital of Joint Logistics Support Force of Chinese People's Liberation Army
state: Gansu
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Nanjing
country: China
facility: General Hospital of the Eastern Theater Cammand of the PLA
state: Jiangsu
city: Shengyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Pudong
country: China
facility: Renji Hospital, Shanghai Jiaotong University
state: Shanghai
city: Pudong
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Analrectal Hospital
state: Sichuan
city: Chengdu
country: China
facility: The General Hospital of Western Theater Command
state: Sichuan
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Army Medical Center (Daping Hospital)
name: Weidong Tong, MD
role: STUDY_DIRECTOR
References:
citation: Macha MR. The feasibility of laparoscopic subtotal colectomy with cecorectal anastomosis in community practice for slow transit constipation. Am J Surg. 2019 May;217(5):974-978. doi: 10.1016/j.amjsurg.2019.03.018. Epub 2019 Mar 26.
citation: Wei D, Cai J, Yang Y, Zhao T, Zhang H, Zhang C, Zhang Y, Zhang J, Cai F. A prospective comparison of short term results and functional recovery after laparoscopic subtotal colectomy and antiperistaltic cecorectal anastomosis with short colonic reservoir vs. long colonic reservoir. BMC Gastroenterol. 2015 Mar 18;15:30. doi: 10.1186/s12876-015-0257-7.
citation: Perivoliotis K, Baloyiannis I, Tzovaras G. Cecorectal (CRA) versus ileorectal (IRA) anastomosis after colectomy for slow transit constipation (STC): a meta-analysis. Int J Colorectal Dis. 2022 Mar;37(3):531-539. doi: 10.1007/s00384-022-04093-y. Epub 2022 Jan 12.
citation: Knowles CH, Grossi U, Horrocks EJ, Pares D, Vollebregt PF, Chapman M, Brown S, Mercer-Jones M, Williams AB, Yiannakou Y, Hooper RJ, Stevens N, Mason J; NIHR CapaCiTY working group; Pelvic floor Society and; European Society of Coloproctology. Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations. Colorectal Dis. 2017 Sep;19 Suppl 3:101-113. doi: 10.1111/codi.13775.
citation: Deng XM, Zhu TY, Wang GJ, Gao BL, Li RX, Wang JT. Laparoscopic total colectomy with ileorectal anastomosis and subtotal colectomy with antiperistaltic cecorectal anastomosis for slow transit constipation. Updates Surg. 2023 Jun;75(4):871-880. doi: 10.1007/s13304-023-01458-y. Epub 2023 Mar 14.