Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Fecal Incontinence

Rectal Neoplasms

Anastomotic Leak

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Postoperative Complications

Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer.

Patients who undergo conventional sphincter-preserving surgeries.

Cheng-Le Zhuang, MD, PhD

Zhong-Chen Liu, MD, PhD

RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.

PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study

The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.

The percentage of patients who develop anastomotic leakage

Ranging from 0 (perfect continence) to 20 (complete incontinence)

Ranging from 0 (perfect continence) to 24 (complete incontinence)

The percentage of patients who preserve the anatomical structure of the anus

The number of grade II and higher postoperative complications according to the Clavien-Dindo classification

The time between the operation date and the discharge date.

Percentage of readmitted patients within 30 days after operation

Disease-free survival is defined as the time from surgery to recurrence of tumor or death

Overall survival is defined as the time from surgery until death from any cause.

Shanghai 10th People's Hospital

Investigator assistant

patients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer

patients who underwent to laparoscopic TME, without elective diverting ileostomy for rectal cancer

elective diverting ileostomy

Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.

From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.

Laparoscopic Surgery of Rectal Cancer and Ileostomy

Laparoscopic Surgery of Rectal Cancer and Ileostomy. Technological Progress in Relation to New Minimally Invasive Treatment Methods and the Incidence of Complications.

Leakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema

post-operative complication in patients submitted to Anterior Rectal Resection

post-operative fever in patients submitted to Anterior Rectal Resection

post-operative surgical site infection in patients submitted to Anterior Rectal Resection

post-operative abdominal collections in patients submitted to Anterior Rectal Resection

post-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection

post-operative perforation in patients submitted to Anterior Rectal Resection

post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer	NCT05245565	Rectum Cancer Stoma Colostomy Faecal Incontin... Leakage, Anasto...		18 Years -	Shanghai 10th People's Hospital
Laparoscopic Surgery of Rectal Cancer and Ileostomy	NCT04169425	Ileostomy - Sto... Ileostomy; Comp... Leakage, Anasto...	elective divert...	67 Years - 86 Years	Campus Bio-Medico University
Laparoscopic Surgery of Rectal Cancer and Ileostomy	NCT04169425	Ileostomy - Sto... Ileostomy; Comp... Leakage, Anasto...	elective divert...	67 Years - 86 Years	Campus Bio-Medico University

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