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Clinical study on the influence of different laxative administration methods on postoperative anastomotic complications of rectal cancer

Clinical study on the influence of different laxative administration methods on postoperative anastomotic complications of rectal cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046057
Enrollment
Unknown
Registered
2021-05-03
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Gastrointestinal diseases

Interventions

The control group:One day before surgery, 411.45g of compound PEG electrolyte was taken orally
Experimental group:Compound polyethylene glycol 274.3g was taken orally 2 days before surgery, and compound polyethylene glycol electrolyte 137.15g was taken orally 1 day before surgery

Sponsors

Shandong First Medical University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or non-pregnant female; 2. American Association of Anesthesiologists ASA Class I-III; 3. According to the preoperative colonoscopy biopsy pathological results, it is confirmed to be rectal adenocarcinoma or high-grade intraepithelial neoplasia; 4. The tumor is located in the rectum; 5. The surgical method is determined to be low rectal anterior resection; 6.Patients who agree to receive adjuvant treatment in accordance with the standard; 7. The patient or family members can understand the purpose of the trial, voluntarily participate in and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. There is distant metastasis, the tumor invades the surrounding organs and requires joint resection of the organs or cannot achieve R0 resection; 2. Past history of malignant tumors or history of bowel surgery; 3. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery; 4. Those who have taken intestinal laxative drugs for a long time; 5. Patients with inflammatory bowel disease, constipation, and irritable bowel syndrome; 6. Those who are allergic to polyethylene glycol electrolyte laxatives; 7. Severe cardiopulmonary disease, long-term use of large amounts of hormones; 8. Those who have taken antibiotics continuously for more than three days within a week before surgery; 9. Those who have participated in other clinical research.

Design outcomes

Primary

MeasureTime frame
The incidence of anastomotic leakage;

Secondary

MeasureTime frame
Infection of incision;Anal tube carrying time;Time of first fluid intake;Application of antidiarrheal drugs after operation;The hospitalization time;albumin;Pre-albumin;infection;Anal canal drainage;

Countries

China

Contacts

Public ContactChen Yuezhi

Shandong First Medical University Affiliated Provincial Hospital

chenyuezhi-007@163.com+86 15168889202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026