Safety and feasibility of single-port robotic ventral patch fixation in the treatment of rectal prolapse (STOPS06)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600119525

Enrollment

Unknown

Registered

2026-02-28

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal prolapse (RP) refers to the intussion of the full thickness or part of the rectal wall into the intestinal cavity. The clinical manifestations of RP include obstructed defecation, anal distension, and incomplete defecation

Interventions

Trial Group:Single-port robotic ventral mesh fixation for rectal surgery (Shuorui single-port laparoscopic robotic surgical system)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Clinical manifestations fulfill the Rome IV criteria for the diagnosis of functional constipation, with symptoms persisting for more than 6 months. 2.Defecography indicates rectal mucosal prolapse graded as Oxford stage III or higher. 3.Age: 18–75 years. 4.American Society of Anesthesiologists (ASA) physical status classification score of 1–3. 5.Failure to respond to conservative medical treatment for more than one year. 6.Patient expresses a strong desire for surgical intervention and has no contraindications to surgery. 7.Patient has provided written informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients diagnosed with megacolon, megarectum, severe spastic constipation, or slow-transit constipation. 2.Pregnant or lactating women. 3.History of prior pelvic surgery. 4.Colonoscopy reveals organic colorectal lesions or a history of colorectal tumor treatment. 5.Presence of moderate-to-severe psychiatric symptoms such as depression or anxiety. 6.Diagnosis of constipation-predominant irritable bowel syndrome (IBS-C). 7.Coexisting inflammatory bowel disease (IBD). 8.Presence of an intestinal stoma without subsequent intestinal anastomosis.

Design outcomes

Primary

Measure	Time frame
Intraoperative conversion rate;	—

Secondary

Measure	Time frame
Intraoperative blood loss;Length of incision;The average length of postoperative hospital stay;Duration of surgery;Incidence of complications within 30 days after surgery;Wexner constipation score;	—

Countries

China

Contacts

Public ContactTong Weidong

Army Medical Center of PLA

vdtong@163.com+86 23 68729356

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026