Symptoms and General Pathology

All Conditions

Diseases and Abnormalities at or Before Birth

Neoplasms

Digestive System Diseases

Constriction, Pathologic

Colic

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Infant, Newborn, Diseases

low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA

with or without Left Colic Artery Preservation

Daorong Wang, M.D., Professor

Brief Summary

Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.

Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function.

The investigators retrospectively collected data from the medical records of participants who had rectal cancer at Northern Jiangsu People's Hospital, from April 2020 to May 2023. A total of 612 from 1164 cases were included in this study; in 462 cases, the LCA was preserved by LL intraoperatively (LL group), in which 202 cases underwent robotic-assisted laparoscopy (LL-RAL subgroup) and 260 cases underwent laparoscopy (LL-LSC subgroup). While in the remaining 150 cases, the LCA was not preserved by HL intraoperatively (HL group). in which 70 cases underwent robotic-assisted laparoscopy (HL-RAL subgroup) and 80 cases underwent laparoscopy (HL-LSC subgroup).

Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation

With or Without Left Colic Artery Preservation

Contains a large amount of personal information about patients and needs to be treated with caution.

Within two weeks after surgery, the patient experienced abdominal pain, fever, and imaging diagnosis showed anastomotic leakage.

The genitourinary function includes urinary dysfunction and sexual dysfunction. Residual urine volume and catheterization retention time for evaluating urinary function. Erectile and ejaculatory grading scores are used to evaluate sexual function.

Northern Jiangsu People's Hospital

Doctor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Traditional laparoscopic surgery for endometrial cancer

Traditional surgery type

Robotic assisted laparoscopic surgery for endometrial cancer

Robotic assisted laparoscopic surgery

The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.

The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.

The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.

Secondary endpoints include:

1. bleeding
2. complications
3. conversions
4. number of pelvic lymph nodes

Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients

Tampere University Hospital

Principal Investigator

Research Subjects will be randomized to Surgical Resection of Rectal Cancer by Standard Laparoscopic Surgery.

Research Subjects will be randomized to Surgical Resection of Rectal Cancer by Robotic Assisted Laparoscopic Surgery.

The research subjects will be randomized to Standard Laparoscopic Surgical procedure to resect their Rectal Cancer.

Standard Laparoscopic Surgery

The research subjects will be randomized Robotic Assisted Laparoscopic Surgical procedure to resect their Rectal Cancer.

Robotic Assisted Laparoscopic Surgery

Alessio Pigazzi, MD

The purpose of this study is to compare two different surgical procedures for the treatment of Rectal Cancer: Laparoscopic Surgery and Robotic Assisted Laparoscopic Surgery. The ROLARR study is for participants with cancer of the rectum for whom a laparoscopic operation (sometimes called "keyhole surgery") has been recommended by their surgeon.

In the past most rectal cancers were removed using "open" surgery. Open surgery involves a large cut down the middle of the patient's abdomen to allow the surgeon to see and take out the cancer. On a previous study showed that using laparoscopic surgery to remove colorectal cancers was as good as open surgery for curing cancer.

There is now another option to remove rectal cancers, which involves using a robotic system with laparoscopic surgery. This type of surgery is called "robotic-assisted" laparoscopic surgery and is now becoming widely used by surgeons to remove cancers including the rectum, as well as for other non-cancer operations.

In order to perform robotic-assisted laparoscopic surgery, the surgeon sits at a robotic control unit a few feet away from the patient. Using the robotic control unit, the surgeon can see a clear video image of the patient's abdomen and the operation site. The surgeon can perform the operation from the robotic control unit by controlling the movement of a set of robotic surgical instruments, guided by the video camera.

Like standard laparoscopic surgery, the surgeon is able to carry out the entire operation through a few small cuts in the abdomen. The camera of the robotic system provides a 3D high-definition magnified view of the operation site and the robotic system is also able to translate the movements of the surgeon's hands into small precise movements inside the patient's body.

We want to test whether robotic-assisted laparoscopic surgery is as good, or even better, at removing rectal cancers as standard laparoscopic surgery (actually Robotic-assisted laparoscopic surgery is used as standard of care in rectal cancer patients at University of California, Irvine Medical Center). We also want to investigate whether using robotic-assisted laparoscopic surgery reduces the number of times a laparoscopic operation needs to be converted to an open operation, and see whether using a robotic system can also shorten the length of time patients need to stay in hospital and if it reduces the number of complications patients may have during and after their operation.

The feasibility and safety of laparoscopic surgery has been established for colon cancer. The case for rectal cancer is less clear, and of the reported multicentre trials only the Medical Research Council (MRC) CLASICC trial included an evaluation of laparoscopic compared to open rectal cancer surgery. Although both laparoscopic and open rectal cancer resection were associated with similar lymph node yields, concern was expressed at the higher rate of circumferential resection margin (CRM) involvement in the laparoscopic arm (12.4%) as compared to the open arm (6.3%) for patients undergoing anterior resection. This however did not translate into a difference in local recurrence at either 3-year or 5-year follow-up. The difference in CRM involvement was felt to reflect the increased technical difficulties associated with the laparoscopic technique in the rectal cancer subgroup. This was supported by the higher conversion rate in the laparoscopic rectal subgroup (34%) as compared to the laparoscopic colon subgroup (25%). Analysis of CLASICC data revealed higher morbidity and mortality rates associated with laparoscopic cases converted to open operation (30-day morbidity: laparoscopic 29%, converted 45%; in-hospital mortality: laparoscopic 1%, converted 9%). Some of this increased morbidity may be related to more advanced cancers requiring conversion, but a proportion will inevitably have resulted from the increased operative time, increased technical difficulty, and the need for a laparotomy wound in converted cases.

The introduction of robotic-assisted laparoscopic surgery using the da Vinci™ system (Intuitive Surgical, California, USA) promises to eliminate many of the technical difficulties inherent in laparoscopic surgery. It offers the advantages of intuitive manipulation of laparoscopic instruments with 7-degrees of freedom of movement, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement, and an ergonomic operating environment. Experience has shown that the benefits of the robot are most appreciated when surgical accuracy is required within a confined space, such as the pelvis.

Laparoscopic rectal cancer surgery is technically demanding requiring accurate pelvic dissection according to total mesorectal excision (TME) principles with autonomic nerve preservation. Inadvertent injury to the nerves has been attributed to the higher rate of male sexual dysfunction following laparoscopic surgery. The practicalities of robotic-assisted colorectal cancer surgery have been reported in small series but only two studies have concentrated on rectal cancer, and only one of these performed a randomised comparison in a small number of patients.

The literature on robotic-assisted colon surgery is limited to 17 small case series. Most of these comprise mixed benign and malignant disease. The largest by D'Annibale et al reported 53 robotic-assisted colectomies and compared outcomes with 53 laparoscopic resections. It concluded that robotic-assisted surgery was as safe and effective as laparoscopic, was particularly useful in pelvic dissection, but that cost-effectiveness needed further evaluation. Other reports concur that robotic-assisted colorectal surgery is feasible and safe, with low rates of conversion, morbidity and mortality, but with increased operative times. There is only one study which has addressed the issue of hospital costs. This compared 30 robotic-assisted with 27 standard laparoscopic cases and concluded that the total hospital cost was higher for robotic surgery.

The feasibility of robotics for TME rectal cancer resection was established by Pigazzi et al in a series of 6 low rectal cancers. A subsequent follow-up study of 39 rectal cancers treated prospectively by robotic-assisted resection reported a zero rate of conversion with a mortality of 0% and morbidity of 12.8%. The only randomised trial compared 18 patients assigned to robotic-assisted resection with 18 patients assigned to standard laparoscopic resection. No difference was observed in the operative times, the conversion rates (2 laparoscopic, 0 robotic), or the quality of mesorectal resection. The only difference was the length of hospital stay, which was significantly shorter following robotic-assisted laparoscopic surgery (robotic-assisted: 6.9 +/-1.3 days; standard laparoscopic: 8.7 +/-1.3 days, p\<0.001) and attributed to a reduction in surgical trauma by the authors. In addition to original reports, there has been one systematic review of robotic-assisted colorectal surgery, which concluded that "robotic colorectal surgery is a promising field and may provide a powerful additional tool for optimal management of more challenging pathology, including rectal cancer".

The current proposal aims to test the hypothesis that robotic-assistance facilitates laparoscopic rectal cancer surgery. On short-term follow-up this should result in a reduction in the conversion rate and no worsening of the CRM positivity rate. On longer-term follow-up, the increased accuracy should improve post-operative bladder and sexual function, enhance quality of life (QoL), and ensure there is no increase in local disease recurrence.

There is a growing enthusiasm for robotics in many surgical specialities. This enthusiasm is often not supported by data on clinical or cost-effectiveness derived from rigorous evaluation by randomised controlled trials. This is the case for robotic-assisted rectal cancer surgery. Given the expense associated with the robotic systems and the limited evidence to support clinical and economic benefits, it is essential that a proper assessment of this new technology is performed in timely manner before its widespread recommendation or implementation. A randomized trial of robotic-assisted versus standard laparoscopic rectal cancer surgery is now urgently needed.

Rationale for current study

The safety and efficacy of robotic-assisted laparoscopic surgery have been established for certain operations, most notably radical prostatectomy. Pelvic surgery, including rectal cancer surgery, lends itself to robotic-assistance. However, the experience with robotic- assisted rectal cancer surgery is limited to a few small personal series and one randomised clinical trial. Although this data suggests it is feasible, it has not established a benefit over standard laparoscopic surgery in terms of technical, functional or oncological outcomes. The primary aim of any curative cancer surgery is complete oncological resection of the tumor with minimal morbidity. It is therefore of utmost importance that prior to the widespread use of robotics in rectal cancer surgery, it is subjected to rigorous evaluation. The use of this new technology incurs additional financial burdens on already overstretched health care resources and it is therefore essential to assess the health economics and cost- effectiveness in comparison to alternative treatments. As this trial is unlikely to be repeated, 3-year outcomes and cost effectiveness will be included within this trial. Specifically, it is aimed to provide information on the ability of the robotic system to facilitate laparoscopic rectal cancer resection, its impact on oncological outcomes (short-term and long-term), its effect on functional outcomes and QoL, and its cost-effectiveness in terms of future healthcare decision-making. Currently, and for the foreseeable future, there is only one surgical robotic system, the da Vinci™ robot. To avoid any criticism of commercial bias, it is imperative that an evaluation of this robotic technology is performed independently of the manufacturer.

Justification for a randomized controlled trial

Since this is a new technology, it is essential that a proper evaluation is performed and disseminated prior to its widespread implementation. A timely assessment is imperative and for this reason there is no plan to perform a prior pilot study, which would inevitably delay evaluation by proper scientific methods. The feasibility of robotic-assisted rectal cancer surgery has already been established and preliminary data upon which to base sample size calculations are available. The time is right for a formal randomised controlled trial to provide a definitive answer to the proposed research question.

Aims and Objectives

The purpose of the trial is to perform a rigorous evaluation of robotic-assisted rectal cancer surgery by means of a randomised, controlled trial. The chosen comparator is standard laparoscopic rectal cancer resection, which is essentially the same procedure but without the use of the robotic device. The two operative interventions will be evaluated for short- and longer-term outcomes. The key short-term outcomes will include assessment of technical ease of the operation, as determined by the clinical indicator of low conversion rate to open operation, and clear pathological resection margins as an indicator of surgical accuracy and improved oncological outcome. In addition, QoL assessment and analysis of cost- effectiveness will be performed to aid evidence-based knowledge to inform National Health Service (NHS) and other service providers and decision-makers. These short-term outcomes will be analyzed after the last randomised patient has had 6 months of follow-up to provide a timely assessment of the new technology, and made available to the public, clinicians and healthcare providers to inform health-care decision making. Longer-term outcomes will concentrate on oncological aspects of the disease and its surgical treatment with analysis of disease-free and overall survival and local recurrence rates at 3-year follow-up.

RObotic Versus LAparoscopic Resection for Rectal Cancer

RObotic Versus LAparoscopic Resection for Rectal Cancer An International, Multicentre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Surgery for Treatment of Rectal Cancer.

All the intra-operative complications will be assessed at 30 days and 6-months after the surgical procedure.

Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 post-operative days.

Overall survival is defined as the time from date of randomization to date of death from any cause. Disease-free survival is defined according to Punt et al's definitions as the time from date of randomization to date of death from any cause, recurrent disease (locoregional or distant recurrence) or second primary cancer.

Patient self-reported bladder and sexual function as assessed by the International Prostatic Symptom Score(I-PSS©) for male and female bladder function, and the International Index of Erectile Function (IIEF) Female Sexual Function Index(FSFI©) for sexual function.

The primary end point is the rate of conversion to open surgery as an indicator of surgical technical difficulty. Conversion is defined as the use of a laparotomy wound for any part of the mesorectal dissection. The use of a limited laparotomy wound to facilitate a low stapled anastomosis and/or specimen extraction is permissible and not defined as an open conversion.

Pathological CRM positivity rates as recorded from local histopathology review, where resection margin positivity is defined as a distance of ≤1mm of the cancer from any resection margin.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation	NCT06376227	Rectal Cancer Left Colic Arte... Robotic Assiste...	with or without...	18 Years - 75 Years	Northern Jiangsu People's Hospital
Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy	NCT01466777	Endometrium Can...	Traditional sur... Robotic assiste...	30 Years - 85 Years	Tampere University Hospital
RObotic Versus LAparoscopic Resection for Rectal Cancer	NCT01736072	Rectal Cancer	Standard Laparo... Robotic Assiste...	18 Years -	University of California, Irvine

Spots Global Cancer Trial Database for robotic assisted laparoscopic surgery