LAPEC for the Treatment of Severe Constipation

NCT03909204 | Unknown DMC

• 1 other identifier: LAPEC for obstipation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Effective treatment for constipation is a real clinical challenge especially in patients with severe symptoms. Dietary measures (bulking agents) and drugs (laxatives, stool softeners, suppositories and enemas etc.) have limited efficacy in severe cases. If conservative measures do not help, surgical therapies might be considered. Subsequently, antegrade enemas through percutaneous colonic catheter were introduced as a less invasive option for treating severe constipation. The cecostomy has been performed laparoscopically, percutaneously, and with the laparoscopic-assisted percutaneous endoscopic cecostomy (LAPEC) technique. This approach allows patients to deliver osmotic agents to the right colon.The procedure has been demonstrated to be safe and effective in young adults and pediatrics. To date, there are only few studies evaluating the safety and efficacy of the LAPEC procedure in adults and all have retrospective profile. The aim of this prospective study is to compare short and long-term efficacy and safety of LAPEC in patients with severe constipation. Symptoms of defecation will be the main outcome criteria.

Conditions

Cecostomy; Complications; Constipation

Keywords

Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy

Outcome Measures

Primary Outcomes (1)

• Change in Bowel QoL

  Main outcome is the proportion of patients with treatment success at 3 and 6 months after the catheter placement. Treatment success is defined as a decrease of Quality of Life symptoms score at least 50% to a baseline values. To assess constipation severity the Knowles Eccersley Scott Symptom (KESS) before and throughout the study will be completed. The KESS is an 11-item tool for diagnosis of constipation. The KESS uses four- to five-point Likert scales that are scored on an unweighted linear integer scale. Total scores can range from 0 (no symptoms) to 39 (high symptom severity).

  Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement

Secondary Outcomes (8)

• Change in Bowel QoL

  3 months, 6 months, 12 months, 24 months

• Removal rate

  12 months

• Transit time

  At 3 and 12 month after PEC placement

• Frequency and Severity of Abdominal Pain

  Data collection will start following consent and procedural training and will be collected daily from day 1 for the duration of the study, an expected average of 12 weeks

• Flush Administration Time

  Data collection will start with the first flush administered following discharge from the hospital and will be collected with every subsequent flush through completion of the study, an expected average of 48 weeks

Study Arms (1)

LAPEC

OTHER

Patients with cecal percutaneous catheter placement.

Procedure: LAPEC

Interventions

LAPEC PROCEDURE

Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy: Initially, one to tree-laparoscopy port technique will be used, with hand placement of seroperitoneal sutures for cecal fixation. After than during colonoscopy a cecal position will be visualized and colonic lumen will be insuflated. After than the PEC tube will be introduced into the cecum using the dilators and sheath. Intravenous antibiotics will be given prior to the procedure and will continued parental temporary and later orally after catheter insertion. One weeks later, antegrade colonic enema will start during an out-patient visit including an educational training of the patient to the catheter manipulation. Antegrade enema solution will start at dose of 2ml/kg and will be increased up to 20ml/kg or a maximum dose of 2000 mL daily. Adjuvant of colonic motility stimulants are allowed during follow-up.

Also known as: Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy

LAPEC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refractory (\> 6 months) and severe (based on a =KESS \>11) and non-invasive therapeutic approaches, including an enhanced fiber diet, lifestyle changes, laxatives, and biofeedback failed.
• Slow transit constipation
• Anorectal malformation
• Mixed constipation (combination of outlet obstruction and slow transit)
• Hirschsprung's disease
• Idiopathic constipation ineffective to standard treatment
• Cauda equine syndrome
• Combination of spina bifida and tethered cord
• Colonic neuropathy.
• Persons 18 years or older at the time of signing the informed consent
• Signed informed consent

You may not qualify if:

• Non-LAPEC cecostomy procedure
• Pre-existing severe electrolyte imbalance
• Chronic high rectal tone
• Advanced liver cirrhosis (Child B or Child C)
• Pregnancy or puerperium
• Advanced colorectal cancer
• Presence of ventriculoperitoneal shunt
• Colonic disease or surgery that might impact safety of percutaneous colostomy tube placement (right hemicolectomy, IC resection, previous apendicostomy) and confirmed inflammatory bowel disease
• Any other condition, which in the opinion of the investigator would interfere with study requirements

Sponsors & Collaborators

• University Hospital Trnava: lead

Study Sites (1)

Rastislav Hustak

Trnava, 917 75, Slovakia

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Radovan Skuta

  Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rastislav Hustak

CONTACT

00421918905728; rhustak@gmail.com

Radovan Skuta

CONTACT

radovan_skuta@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Supportive Care
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: May 20, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 12, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

SL (1)