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Comparison among the 4 different surgical approaches for urinary and sexual function

Evaluation of urinary and sexual dysfunction after rectal resection

Sergio Alfieri, MD

Advances in the treatment of rectal cancer over the past two decades have improved survival and significantly reduced surgery-related morbidity. As a result, post-treatment quality of life (QoL) issues have become increasingly important. Urinary and sexual functions can be significantly altered after rectal resection, mainly due to the iatrogenic lesions of the pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%, respectively. Despite the importance of this topic, most of the studies present in the literature are difficult to interpret for a variety of reasons. Firstly, both sexual and urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data, missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated instruments are the main limitation in drawing conclusive results. As additional factor, no clear evidence is present in the literature regarding the best approach to be used in order to preserve as much as possible both the sexual and urinary functionalities and to guarantee, at the same time, an adequate and oncologically correct rectal resection. Moreover, no data are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary and sexual functionalities. The main objective of the investigator's prospective study will be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas.

Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of the urinary and sexual functions by means of specific questionnaires.

Secondary endpoints will be:

* to investigate which technique (open, robotic, laparoscopic and trans-anal total mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions after radiochemotherapy (NAD+);
* the comparison of both the urinary and sexual dysfunction incidence on the base of the distance of the rectal tumor from the anal verge and the evaluation of the best approach to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor height;
* the short- (postoperative morbidity and histopathological data) and long-term (overall and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and robotic rectal resection.

Urinary and Sexual Dysfunctions Evaluation After Rectal Resection

Multicenter Prospective Evaluation of Urinary and Sexual Dysfunctions After Rectal Cancer Resection

Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Procedure/Surgery: Mesorectal excision with lateral lymph node dissection

Procedure/Surgery: Mesorectal excision without lateral lymph node excision

Mesorectal excision with lateral lymph node dissection

Mesorectal excision without lateral lymph node excision

Shin Fujita, MD

The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer

Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.

Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)

Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)

Ministry of Health, Labour and Welfare, Japan

Haruhiko Fukuda

JCOG Data Center

Infections

Symptoms and General Pathology

Wounds and Injuries

Recurrence

Communicable Diseases

Surgical Wound Infection

Surgical Wound

Wound Infection

Disease Attributes

Postoperative Complications

Patients operated on rectal cancer, included in two compulsory audits of the Catalan Cancer registry and in the Catalan Infection Surveillance Program, who suffered an organ-space surgical infection.

In rectal cancer surgery, the organ/space surgical site infection (O/S-SSI) has an impact on patient's prognosis. Its influence in the oncologic outcomes remains controversial. The main objective is to assess the possible effect of O/S-SSI on long-term overall survival and cancer recurrence.

Colorectal cancer is the third most common malignancy worldwide and the fourth leading cause of cancer death in both sexes, accounting for 30-35% of all tumours originating in the rectum. Although the introduction of total mesorectal excision and the use of neoadjuvant chemoradiation have improved the oncological outcome in patients with rectal cancer operated with curative intent, the 5-year recurrence rate remains around 20%, with tumour stage being the most important prognostic factor. Other tumour-related factors, such as lymphovascular, perineural and extramural vascular invasion, as well as response to neoadjuvant treatment, have also been shown to be reliable predictors of recurrence. However, surgery-related factors, such as the quality of surgical resection as well as the occurrence of postoperative complications, may have a profound impact on these outcomes.

Anastomotic leakage is one of the most serious complications of colorectal surgery and its frequency ranges from 3 to 21% depending on the location of the tumour and the definition of anastomotic leakage used. This complication is associated with considerable morbidity and mortality and may affect quality of life. Several studies have shown that anastomotic leakage and subsequent organ-space infection (O/S-SSI) are also associated with higher rates of tumour recurrence and cancer-specific mortality. A recent meta-analysis involving 43 studies with a total of 154,981 patients undergoing colorectal cancer surgery found that postoperative O/S-SSI and anastomotic leakage had a significant negative impact on disease-free survival, local recurrence and overall recurrence. This association has also been reported after resection of liver metastases and other gastrointestinal malignancies. In addition, the severity of postoperative infection has also been correlated with increased risk of recurrence.

However, these results have not been confirmed in other studies. In our setting, the development of anastomotic leaks did not affect the risk of local recurrence, overall recurrence, overall survival or cancer-specific survival in a multicentre observational study using prospectively collected data from 1181 consecutive rectal cancer patients in 22 hospitals included in the Spanish Rectal Cancer Project. These results were consistent with data reported by national colorectal cancer registries such as those of Denmark and Sweden, among others. Therefore, the question of whether anastomotic leakage contributes to disease recurrence remains controversial and requires further research.

In an attempt to clarify this controversy, a population-based study was conducted to assess the influence of O/S-SSI on recurrence and survival outcomes in patients who had undergone curative surgery for rectal cancer in hospitals integrated in the Public Health System of Catalonia (Spain) at 5-year follow-up.

Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery

Effect of Organ/Space Surgical Site Infection After Rectal Cancer Resection on Five-year Recurrence and Survival Rates. A Population-based Cohort Study of 2208 Patients

Restrictions apply to the availability of these data, which belong to two national databases and are not publicly available. Data was obtained from the Catalan Cancer Plan and VINCat, and are only available with the permission of their Technical Committees.

Overall cancer recurrence included locoregional recurrence and systemic recurrence. Locoregional recurrence was defined as tumor linked with surgical site (anastomosis, tumor bed or mesentery), and systemic recurrence as the disease spreading to organs outside the surgical field, such as the liver, lungs, bones, or brain, confirmed histologically or by imaging.

Overall survival (OS) was defined as the time from surgery to death by any cause.

As described by the Centers for Disease Control: an infection occurring within 30 days of the surgical procedure and involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during surgery. In addition, the patient must present at least one of the following associated events: a purulent drainage from a drain placed into the organ/space

Postoperative complications were classified in accordance with the Clavien-Dindo Classification

Institut d'Investigació Biomèdica de Bellvitge

Institut Català d'Oncologia

Hospital de Granollers

Prof

Diseases and Abnormalities at or Before Birth

Colic

Anastomotic Leak

Herbal and Botanical

All Drugs and Chemicals

Cola

Experimental arm = surgery with IOFA.

In the experimental arm, cancer resection and anastomosis will be performed after assessment of descending colon perfusion using intravenous injection of indocyanine green 0.1ml/kg.

Control arm = Surgery without IOFA.

In the control arm, cancer resection and anastomosis will be performed without intraoperative fluorescence angiography.

In the experimental arm (FLUO+), at least one 0.1mg/kg Infracyanine® bolus will be injected intravenously by the anesthesiologist.

The detection of indocyanine green in the proximal colon segment will be done open or intracorporeally using a dedicated infrared camera.

A surgical film describing the injection technique and fluorescence detection will be presented during the study set-up visits.

An additional injection is allowed at the surgeon's discretion if necessary (change of anastomosis site). The time from injection to indocyanine green detection and any adverse events will be recorded.

FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG).

Zaher Lakkis, MD, PhD

Jean-Baptiste Pretalli, PhD

Jean-Marc Regimbeau

Olivier OULIE, MD

Zaher Lakkis

Pierre Goubault

Nathan Moreno

David ORRY

Bertrand Trilling

Guillaume Piessen

Benoit Gignoux

Eddy Cotte

Régis Fara

Diane Mege

Cécile De Chaisemartin

Laura Beyer-Berjot

Caroline ROSSI

Frédéric MARCHAL, MD PhD

Leon Maggiori

Jérémie Lefèvre

Mahaut LECONTE

Stéphane BENOIST, MD

Gilles MANCEAU, MD

Nelson Trelles

Cyril Perrenot

Veronique DESFOURNEAUX-DENIS, MD

Jean-Jacques Tuech

Antoine Sina

Benoit Romain

Etienne BUSCAIL, MD

Quentin DENOST, MD PhD

Medhi Ouaissi

Cécilia CERIBELLI, MD

Leonor Benhaim

Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC.

The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer.

The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision.

A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited.

In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes.

Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC.

The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer.

The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or handsewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision.

The 26 participating centres are equipped with a scope with near-infrared (NIR) light source allowing real-time ICG perfusion assessment. The co-investigators are experienced digestive surgeons trained to work with and without IOFA. They have considerable experience in working together on research projects and have a proven track-record of efficacy. Moreover, this study will receive valuable support from the Surgery Research Network (FRENCH) and the Surgical Research on Rectal Cancer Group (GRECCAR), which have proved their ability to recruit patients into various multicentric studies and with which the FLUOCOL-1 project has been discussed.

The duration of participation for each patient is 90 days. The 3 study visits are superimposed to the schedule of standard of care (V1: pre-operation visit of selection and inclusion; Surgery; V2: 30-day post-operation visit and V3: 90-day post-operation visit).

The surgeon will do the 1:1 randomization between V1 and the day before surgery (D-30 to D-1). To reduce the risk of bias, patients will be blinded to the study group and the randomization will be stratified on participating centres, Body Mass Index (BMI), physical status classification score (=ASA score), preoperative treatment and tumor location. Patient will be assigned in the intervention (IOFA) or the control group (no IOFA).

At the exception of the information given on the study to the patient, the gathering of the written consent, the randomization and the HRQoL questionnaires, the patient will be treated following standard of care. Study data are the data systematically collected in the patient medical file except for the HRQoL questionnaires that will be collected under the supervision of a research technician financed by the study. The technician will capture the study data and the de-identified pdf version of the medical reports (consultations and hospitalizations) in the electronic Case Report Form (eCRF) after every visit.

A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited.

The ICG will be graciously provided by the manufacturer (SERB). An investigator meeting will be organized twice a year during the annual GRECCAR and FRENCH meetings. Newsletters will be sent every 3 months.

In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes.

Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage

Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage: a Single-blind Phase III Multicenter Randomized Controlled Trial (Intergroup FRENCH-GRECCAR Trial)

The primary outcome is the occurence of an anastomotic leakage during the 90 days following surgery.

Anastomotic leakage is defined as any clinical signs of leakage diagnosed by radiological examination or surgical exploration, or as any isolated pelvic organ infection without leakage evidence, as defined by the International Rectal Cancer Study Group.

Change in planned anastomosis during surgery is defined as any decision change on perfusion assessment such as modifying the initially planned transection level of the descending colon or refashioning anastomosis including the decision to undertake a permanent stoma rather than an anastomosis.

The rate of defunctioning stoma created in the initial surgery as a temporary diverting pathway will be calculated.

Overall 30-day postoperative morbidity is defined and classified according to the Clavien-Dindo classification.

Overall 90-day postoperative morbidity is defined and classified according to the Clavien-Dindo classification.

Postoperative reintervention number and type within 90 days.

Health related quality of life is assessed using the quality of life questionnaires : QLQ-C30 and QLQ-CR29 at baseline and 90 days post-operation.

The QLQ-C30 is a patient self-rating questionnaire (30 questions) that measures physical, role, social, emotional, and cognitive functions as well as overall QoL. Scores can be linearly transformed to provide a score from 0 to 100 REF. Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.

The QLQ-CR29 (Quality of life of rectal cancer patients with 29 questions) has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items. The score can range from 0 to 100.

Higher scores represent better functioning on the functional scales and a higher level of symptoms of the symptom scales.

The medico-economic analysis takes into consideration health care costs up until 90 days post-operation.

Centre Hospitalier Universitaire de Besancon

After rectal resection, when colorectal anastomosis is subperitoneal, it is currently recommended to perform a protective stoma to reduce the potential consequences of a fistula. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature.

The objective of the study is therefore to look for a statistical link between the persistence of a permanent stoma and the intraoperative difficulty represented by pelvic anatomical stress.

Sphincter saving proctectomy

Martin BERTRAND

Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers . A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature. The main risk factor being anastomotic leakage. Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.

Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers . A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature. The main risk factor being anastomotic leakage. Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Studies focused on surgical difficulties usually evaluated criteria such as, total surgery duration, blood loss or surgeon's subjective evaluation. The investigators of this retrospective study hypothesize that when a stoma,primarily intended to be temporary, is not reversed after a long (2 years) post operative delay, it all comes to surgical difficulties and that these surgical difficulties are essentially represented by anatomical constraints. Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.

Is There a Link Between Anatomical Markers of Surgical Difficulty and Incapacity to Reverse Stoma After Low Rectal Cancer Surgery?

Number of patient with the persistence of a permanent stoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Urinary and Sexual Dysfunctions Evaluation After Rectal Resection	NCT04404673	Rectal Cancer	Evaluation of u...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)	NCT00190541	Rectal Neoplasm...	Mesorectal exci... Mesorectal exci...	21 Years - 74 Years	Japan Clinical Oncology Group
Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery	NCT06382415	Rectal Cancer Organ-Space Sur...		18 Years -	Hospital de Granollers
Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage	NCT05168839	Colorectal Canc...	FLUO+ : Intraop...	18 Years -	Centre Hospitalier Universitaire de Besancon
Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage	NCT05168839	Colorectal Canc...	FLUO+ : Intraop...	18 Years -	Centre Hospitalier Universitaire de Besancon
Is There a Link Between Anatomical Markers of Surgical Difficulty and Incapacity to Reverse Stoma After Low Rectal Cancer Surgery?	NCT04006600	Rectal Surgery	Sphincter savin...	18 Years -	Centre Hospitalier Universitaire de Nīmes

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