Clinical Research

Clinical Trials and Research

Comparison of Outcomes Between Robotic-Assisted Laparoscopic Surgery and Conventional Laparoscopic Surgery for Colorectal Disease

• IRB/Protocol Approval: The Methodist Hospital, St Luke’s Episcopal Hospital, University General Hospital, Memorial Hermann Hospital, The Woman’s Hospital of Texas
• Approval Period (Study Status): 12/2009 – Ongoing Enrollment
• Principle Investigator: Eric M. Haas, MD, FACS, FASCRS
• Co-Investigator(s): Stephen S. Chen, MD, PhD
• Study Overview: Several studies have shown that new surgical techniques have the potential of improving outcomes following colorectal surgery. Robotic-assisted laparoscopic surgery has emerged as a viable option for colorectal procedures, offering various visual and operative advantages. The purpose of this study is to compare short-term and pathology outcomes in patients undergoing colorectal surgery, either with robotic-assisted laparoscopic surgery or conventional laparoscopic surgery. The study involves gathering anonymous data from patient records in order to compare and evaluate the efficacy of this new surgical approach with an established surgical technique.

Eligibility for Enrollment: Any individual who is interested in laparoscopic or robotic colon surgery. Contact us to see if you qualify for this trial.

Comparison of Outcomes Between Single-Site Laparoscopic Surgery and Conventional Laparoscopic Surgery for Colectomy

• IRB/Protocol Approval: The Methodist Hospital, St Luke’s Episcopal Hospital, University General Hospital, Memorial Hermann Hospital, The Woman’s Hospital of Texas
• Approval Period (Study Status): 12/2009 – Ongoing Enrollment
• Principle Investigator: Eric M. Haas, MD, FACS, FASCRS
• Co-Investigator(s): T. Bartley Pickron, MD
• Study Overview: Single-site or single-incision laparoscopic surgery offers many potential advantages for the surgical treatment of colorectal diseases. This minimally invasive laparoscopic technique is performed entirely through the umbilicus and results in minimal scar with diminished pain. This trial will compare the clinical outcomes of single-site laparoscopic surgery with those obtained through conventional laparoscopic surgery of the colon and rectum.

Eligibility for Enrollment: Any individual with benign or malignant disease of the colon requiring surgical resection. Contact us to see if you qualify for this trial.

Assessment of Quality of Life (QOL) Following Minimally Invasive Colorectal Surgery

• IRB/Protocol #: HAASQOL2010 (SAIRB)
• Approval Period (Study Status): 4/2010 – Ongoing Enrollment
• Principle Investigator: Eric M. Haas, MD, FACS, FASCRS
• Co-Investigator(s): T. Bartley Pickron, MD, Anne T. Lee, MD, AliMahmood, MD
• Study Overview: Minimally invasive surgery has emerged as a viable option for the treatment of benign and malignant colorectal disease. Comparisons of intra-operative results and post-operative outcomes have been well documented in the literature. While comparisons between laparoscopic and open surgery are well reported, there are few, if any, reports of comparisons between the different types of minimally invasive surgery (e.g., conventional, hand-assisted, single-incision, or robotic-assisted laparoscopic surgery). Short- and long-term outcomes with regard to quality of life are seldom reported following any surgical procedure. The purpose of this study is to assess quality of life outcomes, through completed questionnaires, in patients undergoing minimally invasive surgery for colorectal disease.

Eligibility for Enrollment: Any individual with benign or malignant disease of the colon requiring surgical resection. Contact us to see if you qualify for this trial.

A Prospective Study in Patients With Fecal Incontinence: Evaluating the Clinical and Anatomical Benefits Following the Minimally Invasive SECCA Procedure

• IRB/Protocol Approval: The Methodist Hospital and The Woman’s Hospital of Texas
• Approval Period (Study Status): 3/2010 – Ongoing Enrollment
• Principle Investigator: Eric M. Haas, MD, FACS, FASCRS
• Co-Investigator(s): T. Bartley Pickron, MD, Anne T. Lee, MD
• Overview: Fecal incontinence (FI) affects between 2% and 17% of the population and seriously affects their quality of life. FI is observed most often in females, the elderly, and individuals of poor health. Conservative treatments (e.g., avoidance of spicy foods, increased fiber intake, and bowel retraining programs) are successful for some patients but result in no improvement for others. For these frustrated patients, radiofrequency energy delivery to the anal canal musculature using the SECCA® device may provide a viable option combined with the advantage of a minimally invasive approach. Numerous studies have reported on the safety of SECCA® [Melega et al., 2003; Efron, 2004; Binderow and Cohen, 2009], and outcomes have been assessed with conventional QOL indicators such as the CCFIS and FIQL scores [Efron et al., 2003; Takahashi et al., 2002; Takahashi et al., 2003; Takahashi et al., 2002]. However, the effect of SECCA® has not yet been objectively evaluated using anatomic and functional measurements of sphincter muscle. The purpose of this study is to quantitatively evaluate physiological outcomes (through use of 3D ultrasound and anal manometry) after SECCA® and correlate these with traditionally assessed quality of life outcomes.

Eligibility for Enrollment: Any individual with fecal incontinence that has failed conservative management (nutritional/behavioral modifications). Contact us to see if you qualify for this trial.

Prospective Evaluation of the Effectiveness of Pelvic Muscle Rehabilitation (PMR) as a Non-Invasive Cure for Those With Fecal Incontinence (FI)

• IRB/Protocol #: HAASFI10 (SAIRB)
• Approval Period (Study Status): 3/2010 – Ongoing Enrollment
• Principle Investigator: Eric M. Haas, MD, FACS, FASCRS
• Co-Investigator(s): T. Bartley Pickron, MD, Anne T. Lee, MD, AliMahmood, MD
• Overview: Pelvic muscle rehabilitation (PMR) is a modern and non-invasive treatment modality involving cognitive retraining of the pelvic floor and abdominal wall muscles. Patients are counseled to optimize strength, endurance and reproducibility of pelvic muscle contractions under the guidance of a trained therapist with continuous functional analysis not visible to the patient. Each session consists of: 1) muscle strength and endurance, 2) isolation and control of accessory muscles and 3) electrical muscle stimulation. Each PMR session lasts for approximately 30 minutes and is repeated at 1-2 week intervals. Dietary and behavioral education is discussed at each session and the patient is prescribed a home exercise program. Presently, there are no published reports in regards to the efficacy of PMR for the treatment of FI. The purpose of this study is to assess outcomes of PMR on pelvic floor disorders, specifically fecal incontinence (FI), through quantitative (muscle strength, endurance, fatigue, percent improvement) and qualitative (quality of life questionnaires) measures.

Eligibility for Enrollment: Any individual with fecal incontinence that has failed conservative management (nutritional/behavioral modifications). Contact us to see if you qualify for this trial.

Prospective Evaluation of the Efficacy of Pelvic Muscle Rehabilitation (PMR) as a Non-Invasive Treatment for Obstructive Defecation Syndrome (ODS)

• IRB/Protocol #: HAASODS10 (SAIRB)
• Approval Period (Study Status): 3/2010 – Ongoing Enrollment
• Principle Investigator: Eric M. Haas, MD, FACS, FASCRS
• Co-Investigator(s): T. Bartley Pickron, MD, Anne T. Lee, MD, AliMahmood, MD
• Overview: Pelvic muscle rehabilitation (PMR) is a non-invasive, modern modification of traditional biofeedback involving cognitive retraining of the pelvic floor and abdominal wall muscles. Patients are counseled to optimize strength, endurance and reproducibility of pelvic muscle contractions under the guidance of a trained therapist with continuous anal manometry and electromyography not visible to the patient. Each session consists of: 1) muscle strength and endurance, 2) isolation and control of accessory muscles and 3) electrical muscle stimulation. Each PMR session lasts for approximately 30 minutes and is repeated at 1-2 week intervals. Dietary and behavioral education is discussed at each session and the patient is prescribed a home exercise program. Presently, there are no published reports in regards to the efficacy of PMR for the treatment of ODS. The purpose of this study is to assess outcomes of PMR on pelvic floor disorders, specifically obstructed defecation (ODS)/constipation, through quantitative (muscle strength, endurance, fatigue, percent improvement) and qualitative (quality of life questionnaires) measures.

Eligibility for Enrollment: Any individual with obstructed defecation (constipation) that has failed conservative management (nutritional/behavioral modifications). Contact us to see if you qualify for this trial.