Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807425
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-03-21
Brief Title:
Polidocanol Foam in Hemorrhoidal Disease in Patients With Liver Cirrhosis
Sponsor:
Universidade do Porto
Organization:
Universidade do Porto
Study Overview
Official Title:
Sclerotherapy With Polidocanol Foam in the Treatment of First Second and Third-Grade Hemorrhoidal Disease in Patients With Liver Cirrhosis A Prospective Cohort Trial
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hemorrhoidal disease HD is a common health problem affecting up to 389 of adult population HD is also a common finding in up to 36 of cirrhotic patients as hemorrhoidal plexus is a possible site of portosystemic venous anastomosis Cirrhotic patients represent a group often neglected in clinical trials so little is known about the optimal treatment for HD these patients The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I II and III internal HD with polidocanol foam in cirrhotic patients
Detailed Description:
Hemorrhoidal disease HD is a common health problem affecting up to 389 of adult population Despite being a benign condition associated symptoms like bleeding pain prolapsing swelling itching and mucus soiling impact considerably on patients quality of life HD is also a common finding in up to 36 of cirrhotic patients as hemorrhoidal plexus is a possible site of portosystemic venous anastomosis Despite portal hypertension does not increase the prevalence of hemorrhoids elevated portal venous pressure with a not so rare contribution of coagulopathy may result in massive life-threatening hemorrhoidal bleeding unlike the normal population Besides internal HD bleeding is the most frequently identified cause of bleeding with origin on the lower gastrointestinal tract among cirrhotic patients with severe hematochezia
HD treatment can be grouped into conservative diet lifestyle changes laxatives anti-inflammatory drugs phlebotonics office-based sclerotherapy ligation photocoagulation laser photocoagulation among others and surgical hemorrhoidectomy hemorrhoidopexy The choice of therapy should be oriented by the Golighers classification or a symptom score such as Rørviks Hemorrhoidal Disease Symptom Score HDSS
Cirrhotic patients represent a group often neglected in clinical trials so little is known about the optimal treatment for HD these patients Surgical treatment with stapled hemorrhoidopexy has been described in cirrhotic patients as a feasible and safe approach but with up to 467 of the procedures complicated with postoperative staple-line bleeding although all of them managed with conservative treatment without reoperation or death Recently Ashraf et al compared hemorrhoidectomy performed using rubber band ligation RBL with conventional hemorrhoidectomy in 40 randomized patients with liver disease and diagnosed with grade I II or III HD Intraoperative blood loss was lower in RBL group 12 16 ml vs 222 658 ml p0001 as well as operative time 900 2449 min vs 24100 3669 min p0001 Importantly postoperative pain 35 vs 100 p0001 bleeding 15 vs 45 p0022 and urine retention 20 vs 55 p0011 were lower in the RBL group along with time of hospital stay 86 254 h vs 6065 4193 p0002 and time of wound healing 1685 187 days vs 3100 357 days p0003
Bearing in mind the high rate of surgical complications in cirrhotic patients these results suggest that office-based treatments may be the preferred treatment for cirrhotic patients with HD grades I to III Awad et al compared the efficacy of endoscopic injection sclerotherapy EIS to RBL in the treatment of bleeding internal hemorrhoids in 120 adult patients with liver cirrhosis Both techniques were highly effective in the control of bleeding with a low rebleeding 10 in the EBL group and 1333 in the EIS group and recurrence 20 in the EBL group and 20 in the EIS group rates also EBL had significantly less pain and higher patient satisfaction than EIS However these authors have used liquid sclerosing agents either ethanolamine oleate 5 or N-butyl cyanoacrylate A recent portuguese study by Fernandes et al has evaluated the efficacy and safety of a sclerosing agent polidocanol foam injection in 2000 consecutive patients with prolapsed hemorrhoids grades IIIIIIV This technique showed high efficacy 98 and tolerability 92 with mildno pain with only 07 of serious complications major bleeding n3 urinary retention n4 infectionsuppuration requiring surgery n2 Also in this cohort 210 patients 105 were under anticoagulation or double antiplatelet therapy and only 2 of these patients presented clinically significant bleeding The authors conclude that polidocanol foam should be used as first-line treatment of most hemorrhoid patient including those under anticoagulation and antiplatelet therapy Nevertheless no cirrhotic patients were included so results cannot be generalized to this particular high-risk group
The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I II and III internal hemorrhoidal disease with polidocanol foam in cirrhotic patients
HD treatment can be grouped into conservative diet lifestyle changes laxatives anti-inflammatory drugs phlebotonics office-based sclerotherapy ligation photocoagulation laser photocoagulation among others and surgical hemorrhoidectomy hemorrhoidopexy The choice of therapy should be oriented by the Golighers classification or a symptom score such as Rørviks Hemorrhoidal Disease Symptom Score HDSS
Cirrhotic patients represent a group often neglected in clinical trials so little is known about the optimal treatment for HD these patients Surgical treatment with stapled hemorrhoidopexy has been described in cirrhotic patients as a feasible and safe approach but with up to 467 of the procedures complicated with postoperative staple-line bleeding although all of them managed with conservative treatment without reoperation or death Recently Ashraf et al compared hemorrhoidectomy performed using rubber band ligation RBL with conventional hemorrhoidectomy in 40 randomized patients with liver disease and diagnosed with grade I II or III HD Intraoperative blood loss was lower in RBL group 12 16 ml vs 222 658 ml p0001 as well as operative time 900 2449 min vs 24100 3669 min p0001 Importantly postoperative pain 35 vs 100 p0001 bleeding 15 vs 45 p0022 and urine retention 20 vs 55 p0011 were lower in the RBL group along with time of hospital stay 86 254 h vs 6065 4193 p0002 and time of wound healing 1685 187 days vs 3100 357 days p0003
Bearing in mind the high rate of surgical complications in cirrhotic patients these results suggest that office-based treatments may be the preferred treatment for cirrhotic patients with HD grades I to III Awad et al compared the efficacy of endoscopic injection sclerotherapy EIS to RBL in the treatment of bleeding internal hemorrhoids in 120 adult patients with liver cirrhosis Both techniques were highly effective in the control of bleeding with a low rebleeding 10 in the EBL group and 1333 in the EIS group and recurrence 20 in the EBL group and 20 in the EIS group rates also EBL had significantly less pain and higher patient satisfaction than EIS However these authors have used liquid sclerosing agents either ethanolamine oleate 5 or N-butyl cyanoacrylate A recent portuguese study by Fernandes et al has evaluated the efficacy and safety of a sclerosing agent polidocanol foam injection in 2000 consecutive patients with prolapsed hemorrhoids grades IIIIIIV This technique showed high efficacy 98 and tolerability 92 with mildno pain with only 07 of serious complications major bleeding n3 urinary retention n4 infectionsuppuration requiring surgery n2 Also in this cohort 210 patients 105 were under anticoagulation or double antiplatelet therapy and only 2 of these patients presented clinically significant bleeding The authors conclude that polidocanol foam should be used as first-line treatment of most hemorrhoid patient including those under anticoagulation and antiplatelet therapy Nevertheless no cirrhotic patients were included so results cannot be generalized to this particular high-risk group
The objective of this study is to prospectively evaluate the efficacy and safety of treatment of grade I II and III internal hemorrhoidal disease with polidocanol foam in cirrhotic patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None