LAPEC for the Treatment of Severe Constipation
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|ClinicalTrials.gov Identifier: NCT03909204|
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cecostomy; Complications Constipation||Procedure: LAPEC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Supportive Care|
|Official Title:||Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy (LAPEC) in Adults for the Treatment of Severe Constipation|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 12, 2021|
Patients with cecal percutaneous catheter placement.
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.
Other Name: Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy
- Change in Bowel QoL [ Time Frame: Exit data will be collected at 3 and 6 months after Intake data collection / PEC placement ]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).
- Change in Bowel QoL [ Time Frame: 3 months, 6 months, 12 months, 24 months ]Evolution of Quality of Life questionnaire before and after PEC placement at 3, 6, 12 and 24 months. 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).
- Removal rate [ Time Frame: 12 months ]Proportion of patients with PEC in use and removed.
- Transit time [ Time Frame: At 3 and 12 month after PEC placement ]Change in x-ray transit time
- Frequency and Severity of Abdominal Pain [ Time Frame: 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 ]Frequency and severity of abdominal pain will be recorded daily and measured using the Visual analog pain scale as the appropriate visual analog scale. Score is based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-points line that represents a continuum between the two ends of the scale—"no pain" on the left end (0) of the scale and the "worst pain" on the right end of the scale (10).
- Flush Administration Time [ Time Frame: 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 ]Administration time in minutes per flush will be defined as the time at which the tubing connected to the bag or syringe and the cecostomy fluid starts to infuse into the patient to the time the infusion is completed.
- Flush volume [ Time Frame: 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 ]Volume will be measured and recorded by the patient with each flush and calculated by the investigator in mL/kg using the weight obtained at the clinic visit preceding each effectiveness phase change.
- Procedural adverse event [ Time Frame: 1 month ]Perioperative adverse events (complications)
- Long-term adverse events [ Time Frame: 3, 6, 12, 24 months ]Incidence rate of adverse events during follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909204
|Contact: Rastislav Hustakfirstname.lastname@example.org|
|Contact: Radovan Skutaemail@example.com|
|Rastislav Hustak||Not yet recruiting|
|Trnava, Slovakia, 917 75|
|Contact: Rastislav Hustak firstname.lastname@example.org|
|Contact: Radovan Skuta email@example.com|
|Principal Investigator:||Radovan Skuta||Surgeon|