Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Syndrome

Low Anterior Resection Syndrome

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients undergoing open low anterior resection

Patients undergoing laparoscopic low anterior resection

Patients undergoing robotic low anterior resection

Patients undergoing transanal Total Mesorectal Excision (taTME)

Open approach for Total Mesorectal Excision

Open Total Mesorectal Excision

Laparoscopic approach for Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision

Robotic approach for Total Mesorectal Excision

Robotic Total Mesorectal Excision

Transanal approach for Total Mesorectal Excision

Transanal Total Mesorectal Excision

Patricia Tejedor

Carlos Pastor

The surgical management of rectal cancer includes a Total Mesorectal Excison (TME); depending on the height of the tumor, the problem of preservation of the anal sphincter arises, being able to perform a low anterior resection, an ultra-low anterior resection (RAUB) or an intersphincteric dissection. In some cases invading the sphincters or the puborectalis muscle, an abdominoperineal resection needs to be performed, being the gold standard in this particular situation so far.

TME can be performed by open, laparoscopic, robotic or transanal approaches, as long as the oncological principles for the resection are achieved. Unfortunately, up to 90% of these patients will present a change in bowel habit, ranging from an increased frequency of bowel movements to the degree of fecal incontinence or evacuation dysfunction. Of these patients, 25-50% will have a severe alteration in the quality of life. This wide spectrum of symptoms has been called "low anterior resection syndrome" (LARS). Other collateral damage is the change in sexual and urinary function, due to hypogastric plexus injury. There is a significant lack of multicenter prospective studies that provide evidence, and that reveal the functional results and quality of life of these techniques available to date for the management of rectal cancer.

The study is set up as a prospective multicentre observational study. Inclusion criteria are: 1) patients over 18 years old, 2) diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI, 3) undergoing Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches, 4) with/without derivative stoma and 5) with/without neoadjuvant treatment. Exclusion criteria are: 1) Upper rectal cancer, located above the peritoneal reflection, 2) previous radical prostatectomy, 3) previous pelvic radiotherapy, 4) rectal resection without primary anastomosis, 5) intraoperative findings of peritoneal carcinomatosis, 6) stage IV disease, 7) multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder, 8) rectal resection due to a benign condition, 9) rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm), 10) rectal resection following a 'watch \& wait' program, 11) emergency surgery, 12) previous derivative colostomy 13) inflammatory bowel disease.

Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 45 subjects are necessary in first group and 45 in the second to recognize as statistically significant a difference greater than or equal to 2 units. The common standard deviation is assumed to be 3. It has been anticipated a drop-out rate of 20% Primary outcomes are LARS and Vaizey score. Secondary outcomes included are QLQ C30 and CR29, sexual function questionnaire (female/male), urinary function questionnaire and postoperative complications (Clavien-Dindo classification) Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (September 2021 - September 2023).

It is essential to have a validated instrument that allows us to assess sphincter function and the different aspects of quality of life in operated patients, since increased survival in this pathology has led to greater importance in the evaluation functional outcome and quality of life; Furthermore, there are recent studies that speak of the direct relationship between these factors.

Patient Reported Outcomes Following Cancer of the Rectum

LARS score from 0-42 where 0 means better outcomes

Incontinence score from 0-28 where 0 means better outcomes

Quality of life questionnaire, colorectal cancer related

University of Navarrra Hospital (Clinica Universitaria)

Hospital de Leon

Hospital del Río Hortega

University Hospital Gregorio Marañón

Principal Investigator

Infections

Communicable Diseases

Postoperative Complications

Fecal Incontinence

Abscess

Abdominoperineal excision with intersphincteric dissection and a stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity

Hartmann´s operation and stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity

Abdominal operation where the rectum is resected down to the levator and then the anus is resected by an intersphincteric dissection and order to leave the outer sfincter and levator in place to avoid a large wound and a high rate of infectious complications.

APE with intersphincteric dissection

Abdominal operation where the rectum is resected and stapled off distally and a stoma is created

Hartmann´s procedure

Kenneth Smedh, PhD

In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal anastomoses is the gold standard. However, in patients with a weak sphincter and fecal incontinence or in patients with severe co-morbidity and reduced general condition, this operation is not suitable.

In these situations there are two other radical surgical options, Hartmanns procedure and the Abdominoperineal excision that can be performed with intersphincteric dissection to minimise perineal complications.There are no data on which of these procedures that are best suited for these patients with fecal incontinence or severe co-morbidity( at risk for life-threatening anastomotic leak). In this randomized study we intend to compare postoperative complications within 30 days after these two procedures and also late complications and quality of life after one year postoperatively.

In patients with rectal cancer, an abdominal operation with anterior resection with total mesorectal excision is the gold standard. Colon is anastomosed to the ano-rectum.The potential risks are bad bowel function with fecal incontinence or a lifethreatening anastomotic dehiscence, especially in patients with severe co-morbidity or reduced general condition.Tumours in the low rectum are usually treated with an abdominoperineal resection where the whole anus is radically excised and a permanent colostomy is created.

For patients with incontinence and/or severe comorbidity, Hartmann´s procedure has often been performed. The rectum is resected, the lower part is transected with a stapler and a colostomy is created. During recent years there has been reports on high rates of pelvic abscesses after Hartmann´s. An alternative has been proposed, namely the abdominoperineal excision (APE) with intersphincteric dissection leaving the outer sphincter and levator muscles in place, thus creating a much lesser perineal wound that also tend to heal better when the ano-pelvic muscles are left in place.

There have been some small retrospective studies comparing postoperative complications after Hartmann´s with anterior resections or the classic abdominoperineal excision. These studies are heterogenous and not balanced and no conclusions can be drawn. There are no data on APE with intersphincteric dissection in rectal cancer patients.

There is a need to clarify what procedure is most suited for patients with rectal cancer and fecal incontinence and / or severe comorbidity.

For this patient group we intend to randomize between Hartmann´s procedure and APE with intersphincteric dissection.

Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study

QoL protocol according to the QoLiRECT-study (Quality of life rectal cancer study) a study running from Gothenburg, Sweden

Perineal pain, secretion from the ano-rectal stump

Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc

time of surgery, bleeding in ml, peroperative complications, type of staplers used

record perforation of rectum or tumour during surgery

Record local recurrence during follow-up. CT-scan after 1 and 3 years

reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation

other infectious, cardio-pulmonary and thromb-embolic complications.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study	NCT01995396	Rectal Cancer Sphincter Ani I... Other Diagnoses...	APE with inters... Hartmann´s proc...	18 Years -	Region Västmanland
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Patient Reported Outcomes Following Cancer of the Rectum	NCT04936581	Sphincter Ani I... Rectal Cancer	Open Total Meso... Laparoscopic To... Robotic Total M... Transanal Total...	18 Years - 100 Years	University Hospital Gregorio Marañón
Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study	NCT01995396	Rectal Cancer Sphincter Ani I... Other Diagnoses...	APE with inters... Hartmann´s proc...	18 Years -	Region Västmanland

Spots Global Cancer Trial Database for sphincter ani incontinence